Iso 7886 1 Pdf Free Download
Plastic syringes are Class IA medical devices which are used frequently for the administration of drugs parenterally. Syringes and their materials have to fulfil the tests like transparency, water vapor permeability, leakage and cytotoxicity. These tests are indicated in pharmacopoeias and they are applied for the understanding whether is suitable to standard. Also they obey to some requirements such as electrical properties, sterility, chemical resistance and extractables/ leachables. These requirements are indicated in standards. In this article, firstly the requirements and tests are mentioned. Afterwards, sterilization of plastic syringes with ethylene oxide or radiation and the effects of radiation sterilization on the plastic syringe materials are explained. Finally, several studies done on the possible interaction between plastic materials of syringes and some chemical solutions have been summarized. Tıbbi Cihaz Olarak Enjektörler ÖZET Plastik şırıngalar sıklıkla ilaçları parenteral yoldan uygulamak için kullanılan Sınıf IA tıbbi cihazlardır. Şırıngalar ve şırıngaların yapıldıkları malzemeler şeffaflık, su buharı geçirgenliği, sızdırma ve sitotoksisite gibi testleri geçmek zorundadır. Bu testler şırıngaların ve malzemelerin standartlara uyup uymadığını saptamak için yapılır ve farmakopelerde belirtilmiştir. Ayrıca şırıngalar elektriksel özellikler, sterilite, kimyasal direnç ve ekstre edilebilir maddeler/ ağartıcılar bakımından bazı gerekliliklere uymak zorundadırlar. Bu gereklilikler standartlarda belirtilmiştir. Bu makalede, ilk olarak bu gereklilikler ve testlerden bahsedilmiştir. Ardından plastik şırıngaların etilen oksit veya radyasyon ile sterilizasyonu ve plastik şırınga malzemeleri üzerinde radyasyonla sterilizasyonun etkileri açıklanmıştır. Son olarak plastik şırınga materyali ve bazı kimyasal çözeltiler arasında oluşabilecek etkileşimle ilgili yapılan çalışmalar özetlenmiştir.
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FABAD J. Pharm. Sci., 41, 27-37, 2016
Syringes As Medical Devices
Merve KARPUZ*,**, A. Yekta ÖZER*°
REVIEW ARTICLES
27
* Hacettepe University, Faculty of Pharmacy, Department of Radiopharmacy, 06100, Sıhhiye, Ankara-Turkey.
** İzmir Katip Çelebi University, Faculty of Pharmacy, Department of Radiopharmacy, 35620, Çiğli, İzmir-Turkey.
°Corresponding Author:
Phone: +90 312 305 21 96
Fax: +90 312 311 47 77
E-mail : yktzer@yahoo.com
Syrnges As Medcal Devces
SUMMARY
Plastc syrnges are Class IA medcal devces whch are used
frequently for the admnstraton of drugs parenterally. Syrnges and
ther materals have to fulfl the tests lke transparency, water vapor
permeablty, leakage and cytotoxcty. ese tests are ndcated n
pharmacopoeas and they are appled for the understandng whether
s sutable to standard. Also they obey to some requrements such as
electrcal propertes, sterlty, chemcal resstance and extractables/
leachables. ese requrements are ndcated n standards. In ths
artcle, frstly the requrements and tests are mentoned. Afterwards,
sterlzaton of plastc syrnges wth ethylene oxde or radaton and
the eects of radaton sterlzaton on the plastc syrnge materals
are explaned. Fnally, several studes done on the possble nteracton
between plastc materals of syrnges and some chemcal solutons
have been summarzed.
Key Words: Syrnges, Sterlzaton, Radaton sterlzaton,
Radaton eects on plastc materal, Chemcal nteracton n plastc
syrnges.
Received: 12.12.2016
Revised: 20.01.2017
Accepted: 23.01.2017
Tıbb Chaz Olarak Enjektörler
ÖZET
Plastk şırıngalar sıklıkla laçları parenteral yoldan uygulamak çn
kullanılan Sınıf IA tıbb chazlardır. Şırıngalar ve şırıngaların
yapıldıkları malzemeler şeaık, su buharı geçrgenlğ, sızdırma ve
stotoksste gb testler geçmek zorundadır. Bu testler şırıngaların
ve malzemelern standartlara uyup uymadığını saptamak çn
yapılır ve farmakopelerde belrtlmştr. Ayrıca şırıngalar elektrksel
özellkler, sterlte, kmyasal drenç ve ekstre edleblr maddeler/
ağartıcılar bakımından bazı gerekllklere uymak zorundadırlar.
Bu gerekllkler standartlarda belrtlmştr. Bu makalede, lk
olarak bu gerekllkler ve testlerden bahsedlmştr. Ardından plastk
şırıngaların etlen okst veya radyasyon le sterlzasyonu ve plastk
şırınga malzemeler üzernde radyasyonla sterlzasyonun etkler
açıklanmıştır. Son olarak plastk şırınga materyal ve bazı kmyasal
çözeltler arasında oluşablecek etkleşmle lgl yapılan çalışmalar
özetlenmştr.
Anahtar kelimeler: Şırıngalar, Sterilizasyon, Radyasyonla
Sterilizasyon, Plastik materyaller üzerine radyasyonun etkisi,
Plastik şırınga materyalindeki kimyasal etkileşmeler.
28
Karpuz, Özer
INTRODUCTION
ere are four major systemic routes for the
administration of drugs to the body: enteral,
parenteral, transdermal and inhalation. Parenteral
routes have some advantages such as quick drug
eect, 100 % bioavailability, protecting drugs from the
eect of gastrointestinal system and preventing the
formation of inactive drugs before drug eects occur
(Oktay & Kayaalp, 2012). Plastic syringes are the most
commonly used instruments for the administration
of drugs parenterally and they are medical devices
designated as Class IA.
e first study, which is about administration of
drugs into the body through the skin, was made by
Magendie in 1809. For this purpose, he administered
strychnine into a dog by using a wood coated thorn.
Aer that, Lafargue introduced morphine by using
a lancet. Rynd invented a dripping needle in 1844.
Finally in 1853 by Wood, first real syringe was
invented for the purpose of treating birthmarks and
a few years later aer this date, he added a barrel and
a better needle to this invention (How Products Are
Made Volume 3 Syringe).
TYPES and CLASSIFICATION of SYRINGES
Syringes are named according to the volume
and the usage purpose and they are classified into
disposable syringes and non-disposable syringes. In
Table 1, types of syringes and the commercial samples
are summarized. Disposable syringes are sterile,
packed, ready for use, non-toxic, non-pyrogenic and
have lower risk in transmitting the diseases such as
AIDS or Hepatitis B than non-disposable syringes.
So they are preferred mostly. Non-disposable
syringes are generally made of heat-resistant glass
such as borosilicate and they are not used very oen
(Pharmacology chapter).
ere are 2 type of syringes according to intended
use; oral and hypodermic.
Oral syringes are used eiciently in the
administration of drugs by oral or enteral route
and the preparation of drugs which have very small
volume (Grissinger, 2013).
Hypodermic syringes are calibrated by cubic
centimeter (cc), mililitre (ml) or unit. Small volume
syringes, which have 1, 2, 2.5, 3 ml volumes, are used
in the administration of the intramuscular (i.m.)
or subcutan (s.c.) injections. Syringes which have
larger volumes such as 5, 6, 10, 12 ml, are used in the
blood draw from patients or in the preparation of the
drugs for intravenous (i.v.) injections and syringes,
which have larger volume than 20 ml, are used in the
injections of larger volume sterile solutions (Chapter
7 Syringes).
In accordance with the special intented use, there
are 3 types of syringes: Insulin, Tuberculin and Pre-
filled Syringes.
Insulin syringes are used in the injection of
insulin hormone, which takes place in the treatment
of Insulin Dependent Diabetes Mellitus and they are
calibrated by unit (Chapter 7 Syringes).
Other syringe type is Tuberculin syringes which
are used in the diagnosis of tuberculosis. eir volumes
are 1 ml and on the syringe barrel there are 100 lines
which show 0.01 ml each. is type of syringes are
used for intradermal (i.d.) injection of very small
volume drugs which are used in tubeculosis and
allergy tests. Also, they are preferred for i.m. injection
of the drugs which have small volumes lower than 1
ml (Chapter 7 Syringes).
When types of syringes are mentioned, pre-filled
syringes mustn't be forgotten. Pre-filled syringes ,
which are used for the administration of the various
liquid drugs (such as insulin or vaccines), are single
dose cartridges that have fixed needles on it (Dunne &
Whitaker, 2016). ere are a lot of advantages of pre-
filled syringes over traditional vials and ampoules for
the patients and health workers (Yoshino et al. ,2014;
Makwana et al.,2011):
Minimizing of the drug waste,
Extra time for the drug shelf life,
Being eective, safe and useful,
Providing of the precise dose drug
administration rapidly,
Minimizing of dose mistakes and risk of
biological contamination,
Allowing the patients administration of
drugs by themselves out of the hospital.
Pre-filled insulin syringes especially are
recommended for the patients, who use insulin in
diabetes treatment, because of adsorption eect of
plastic syringes (Dunne & Whitaker, 2016). In the
production of this type of syringes, Class I borosilicate
glass for syringe barrel; stainless steel or elastomer
for needle; elastomer for plunger and cap and plastic
materials for the other pieces of the syringe are
used, respectively. e plastic materials used in the
production are cyclo olefin polymers (COP) or cyclic
olefin copolymers (COC). In the sterilization of these
types of syringes, autoclave or ionized radiation can
be used but the main sterilization method is gamma
radiation sterilization (Makwana et al., 2011).
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FABAD J. Pharm. Sci., 41, 27-37, 2016
Table: 1. Types of Syringes
According to Material 1. Plastic Syringes
1.1. Polypropylene (Hayat®, Sigma-Aldrich®)
1.2. Polyethylene (Sigma-Aldrich®, Norm-Ject ®)
2. Glass Syringes (Sanitex ®)
According to Administration Route 1. Hypodermic Syringes (Hayat®)
2. Oral syringes (BD UniVia™)
According to Special Intended Use 1. Tuberculin Syringes (MonojectTM)
2. Insulin Syringes (GNP®)
3. Pre-filled Syringes (Mırcera®)
MATERIALS of SYRINGES
Although a lot of syringes have been designed until
now, all of the syringe types basically have the same
pieces like plunger, barrel, needle and cap as shown in
Figure 1 (How Products Are Made Volume 3 Syringe).
Figure: 1. Syringe and Pieces (Syringes).
If the syringe needle is made of stainless steel, it
is hypodermic type needle. ere are some methods
for measuring the diameter of the syringe needle such
as French Catheter Gauge, Metric Sizes in Milimeters,
Stubs Wire Gauge. Among them Stubs Wire Gauge
method is the most frequently used for medical
catheters and equipment in worldwide. In accordance
with this system, if the aperture of pinhole is 0.134
inch it is called 10 gauge and is 0.035 inch for the 20
gauge (Kucklick, 2006).
Syringe plunger, barrel and cap are made of
polypropylene (PP) or polyethylene (PE) plastic
materials. ese materials must be at medical grade
because of their medical use. For this purpose, some
essential tests are applied to the plastic materials and
the materials are characterized by their composition,
mechanical- thermal and electrical properties,
sterility, chemical resistance and extractables/
leachables, biocompatibility, hemocompatibility
and stability. Among them mechanical thermal and
electrical properties, sterility, chemical resistance
and extractables/ leachables are the most important
properties of the produced syringes. Biocompatibility
and hemocompatibility are not very important
because of no contact in between the syringe barrels
and skin or blood (Sastri, 2014).
Some test methods, like combustion, extractable
substances, fine particles, transparency, water vapor
permeability, leakage and cytotoxicity, take place in
pharmacopeias. Depending on the results of these test
methods, the requirements for PP and PE containers,
which are used for aqueous injection, are indicated.
According to Japanese Pharmacopeia (2011a):
• Transparency : When it is tested as defined
at pharmacopoeia, material transmittance is not less
than 55%. At sensory test, turbidity is not more than
20% in the water loaded container and also being
turbid is not more than 80% in the suspension loaded
container.
• Appearance: Materials must not include
cracks or bubbles.
• Water Vapor Permeability: Depending on the
results of tests which are defined pharmacopoeial test
methods, the loss of mass is not more than 0.2%.
• Heavy Metals: e turbidity of the test solution
must not greater than that of the control solution.
• Cadmium: According to the results of applied
test, the absorbance of the test solution must not be
dierent from control's absorbance.
• Residue on Ignition: is must not be more
than 0.1% in 5 gram.
• Foaming Test: e foam must disappear in 3
minutes.
• pH: e pH dierence in between the blank
and test solution is not more than 1.5.
• UV Spectrum: In 220-240 nm it must not be
more than 0.08 and in 241-350 nm it must not be
more than 0.05.
• Residue on Evaporation: It must not be more
than 1.0 mg.
• Half Maximal Inhibitory Concentration
(IC50 ): It must not be more than 90%.
According to European Pharmacopeia (2008a):
• Appearance of S Solution: S solution, which is
prepared with suicient number of syringes, must be
clear and colourless.
• Acidity or alkalinity: When 0.1 ml
30
Karpuz, Özer
bromothymol blue added to 20 ml S solution is
titrated with 0.01 M HCl or NaOH, the amount of acid
or alcali must not be used more than 0.3 ml.
• Absorbance: In between 230-306 nm, it must
not be more than 0.2.
• Reducing Agents: When the S solution and
blank solution (fitting to phar macopeial requirements)
are titrated with 0.01 M sodium thiosulfate solution,
the dierence between the volumes should not be
more than 1.5 ml.
PRODUCTION of SYRINGES
Along the process of syringe production, some
tests are applied to syringes in order to understand
whether the requirements were provided or not. is
tests and requirements are indicated in national and
international standards which are summarized in
Table: 2.
Table: 2. National and International Standards for Syringes
TS EN ISO 8537 Sterile single-use syringes, with or without needle, for insulin
TS EN ISO 21533/AC Dentistry - Reusable cartridge syringes intended for intraligamentary injections
TS EN ISO 7886-1 Syringes-Hypodermic-Single use, sterile Part1: Syringes-Manual
TS EN ISO 7886-2 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe
pump
TS EN ISO 7886-3 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization
TS EN ISO 7886-4 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
TS ISO 11040-3 Prefilled syringes - Part 3: Seals for dental local anesthetic cartridges
TS 3592 Needles for Syringes
TS 4021 Ear Syringe- Metal
TS 5031 Insulin Syringes-Reusable
TS 5462 Tuberculin Syringes
TS EN ISO 9997 Dental Cartridge Syringes
According to TS EN ISO 7886-1 (1998), TS EN
ISO 7886-2 (2006), TS EN ISO 7886-4 (2007):
When the syringe pieces (plunger, barrel, needle
and cap) are investigated in between 300 and 700 lux-
light without magnifying glass, the syringe surfaces
which are directly contact with injection liquids, must
not include particles or impurities.
For the evaluation of pH value and amount
of extractable metals, at least 3 syringes are filled to
nominal capacity line with distilled water which is
suitable for the third degree in TS ISO 3696 and they
are kept throughout 8 hours (0/+15 min.) at 37 (0/+3)
oC. In order to evaluate the needle of the syringe
pH, 25 needles are immersed in distilled water and
kept throughout 60±2 minutes. e content was
decanted to a borosilicate glass and is compared with
control solutions which are prepared from freshly
distilled water. When the pH values of the content are
compared, it must not be higher 1 unit than control
solution. Total amount of lead, tin, zinc and iron
must not be higher than 5 mg.L-1 and also amount of
cadmium must be less than 0.1 mg.L-1.
If any lubricant is used for the inner surfaces of
syringe barrels and needles, particle of lubricant, which
is in droplet form, must not be seen at visual inspection.
For three pieces syringes, polydimethylsiloxane must
be used as lubricant and its amount must not be higher
than 0.25 mg. Also, in two pieces syringes amide of
erucic and oleic acids must be used as lubricant and
the amount of lubricant must not exceed 6% (m.m-1 )
the mass of the cylinder.
e pinpoint of syringe must be sharp and
smooth.
Syringe has to have identical scale which is
calibrated in one or more interval and volume of
syringe must be shown at syringe barrel.
e length of syringe barrel is suitable to
provide maximum usable capacity which must be at
least 10 % more than the nominal capacity.
Syringes must have finger grips which prevent
rotation more than 180 degrees when syringes are
placed horizontally at at which is angled 10 degree
with horizontal plane. In addition, finger grips must be
in appropriate shape, measure and resistance and they
must not have sharp edge or bulge.
When the barrel of syringe is held in one hand,
the plunger can be pushed by the same hand. For this
purpose, syringe nozzle is connected to reference
steel cone and syringe fills with water. While negative
pressure is applied from nozzle, possible disconnection
between piston and the body of piston is checked.
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FABAD J. Pharm. Sci., 41, 27-37, 2016
When the syringe filled with water and hold
vertically, body of piston must not move because of
its weight. e force for the movement of piston body
and to fill water to the syringe or to discharge the
water from the syringe is determined by mechanical
experiment machine.
Fiducial line must be contacted with the inner
surface of barrel.
According to TS 3521-1 EN20594-1, syringe
nozzle must be compatible with conical connection
and nozzle lumen must not be less than 1.2 mm.
In order to understand the void volume in
syringe, the dry syringe is weighted and filled with
water, discharged, syringe's outer surface is dried and
it is reweighted. e void volume is calculated from
the weight of the residual water. is finding is in
accordance with the value mentioned in the standards.
To test the air and liquid leakage, the syringe
is filled with water, syringe nozzle is closed, a force is
applied to piston and possible amount of leakage is
checked.
Flow properties of syringe is determined by
using reference syringe driver. Depending on the
results of this method, the time which is necessary for
reaching at least 95% level, fixed ow speed is set by
the movement of piston rod's push button must not
exceed 10 minutes. Total percentage of error of ow/
set distribution speed, must not be higher than ±2%.
e force which is necessary for the drainage of
water is determined by a mechanical machine. At the
end of these experiments, the determined force must
appropriate to the designated values in standards.
Packaging and labeling which are the last steps
of the syringe production, should be appropriate to the
designated values in standards.
STERILIZATION of SYRINGES
According to the old definition, sterilization is
the elimination of all the alive organism, bacteria and
fungi spores and saving the contents of products from
microorganisms, absolutely.
Recently, sterilization is defined as the presence
probability of viable microorganism in one million
product.
eoretically, in order to designate a medical device
as sterile, the probability level shou ld be lower than one
to a million (Perçin, 2014). Sterility Assurance Level
(SAL) is the term used for expression of reaching of
the sterility to the desired level. In other words, SAL is
a term which can be defined as probability of presence
non-sterile products or survival of microorganisms in
the samples. For medical devices SAL level is very low
like 10-6 (Turker, 2009a.; Sterility Assurance Level).
Among the main sterilization methods, there are
several sterilization methods like sterilization with
dry air at oven, sterilization with pressurized steam
in autoclave at 121oC, UV radiation sterilization,
ethylene oxide (EO) sterilization, ionized radiation
sterilization which uses gamma rays or electron beam
(e-beam) and sterilization in aseptic conditions by
using membrane filters which have pores in 0.22 µm
diameter (Silindir & Ozer, 2009; Moraes et al., 2014).
Syringes have to be sterile because of their use in
the administration of sterile and apyrogenic drugs by
parenteral route. Sterilization of products is possible
in the terminal packages. Microbial death/ bioburden
control are evaluated by this method and has the lowest
risk. Because of these reasons, terminal sterilization
method is recommended (Japenese Pharmacopoeia,
2011b ).
Among the sterilization methods, there are two
methods used for the sterilization of syringes. One
of them is EO sterilization which has been used
since the 1950s. is method is especially suitable for
heat-sensitive and moisture-sensitive materials. Pure
EO gas is ammable and explosive, also according
to Environmental Protection Agency (EPA) toxic
and carcinogenic gas. So EO gas is diluted with
some agents like hydrochlorouorocarbon (HCFC)
and carbon dioxide. ere are some disadvantages
of this method; for instance it is complex because
of depending on some critical parameters such as
temperature (30-65oC), amount of relative humidity
present (30-99%), EO concentration (250-1500
mg.ml-1 ), overall exposure time (1-30 hours), type of
microorganisms, product and load density, and gas
permeability factors. In addition, due to the formation
of EO decomposition products aer sterilization
process it requires aeration (Sastri, 2014; Silindir &
Ozer, 2009; United States Pharmacopeia, 2009).
Other sterilization method is ionized radiation
sterilization which uses gamma rays or e-beam. In
order to apply this sterilization method in pratice, the
first national dra law has been published in 1965.
Nowadays, there are Food and Drug Administration
(FDA) in USA and Department of Health and Social
Services (DHSS) in UK for checking the suitability
of facilities with laws and regulations. In addition,
Occupational Safety and Health Administration
(OSHA) and Environmental Protection Agency (EPA),
which was established in 1997 within the framework
US Clean Air Act, specify sine qua non about the
safety of personnel and the protection of environment.
Before mentioned authorities and International
Atomic Energy Agency (IAEA) determine the high
standards on international basis; among these:
32
Karpuz, Özer
providing the safety running of radiation sources
and application of appropriate radiation doses to the
products steadily, providing radiation sterilization use
in industry (Fairand, 2002).
e radiation energy is supplied by accelerators,
which provides 10 MeV power of e-beam or 60 Co
radionuclide which emits 1.33 MeV power of gamma
rays. Sterilization with e-beam has some advantages
(Silindir & Ozer, 2009; Fintzou et al., 2007a, 2007b;
Haji-Saeida, 2007):
(a) Safe and reliable method,
(b) Ease of control,
(c) High dose rate,
(d) Insignificant increasing of temperature.
On the other hand, penetration of gamma rays is
higher than e-beam, so this makes that gamma rays is
more popular than e-beam. In addition, in the e-beam
irradiation the applied dose rate is higher but the time
is shorter than at gamma irradiation. For instance,
there is an equality between 15 kW e-beam and 1 MCi
gamma sources. e radiation dose for sterilization is
changing in between 25 and 40 kGy. e application
dose must be identified before the sterilization of
syringes in order to show relationship between dose
range and remaining of non-sterile items. Also, by the
identification of dose rate, application of unsuitable
radiation dose which is lower than eective sterilization
dose, is prevented (Fintzou et al., 2007a, 2007b;
Haji-Saeida et al. , 2007; Ley et al., 1972). In order to
reach the desired SAL level, suitable radiation dose is
determined by using Bacillus Pumilus spores which
are the most resistant microorganism to irradiation.
For this purpose, the samples obtained from products
produced properly according to Good Manufacturing
Practice (GMP) conditions, are contaminated by
Bacillus Pumilus spores and in this way microbial
bioburden is created. Microbal bioburden is the
number of alive microorganisms on the products
which will be sterilized, and is determined in fours
steps (Berk, 2002a, 2002b):
I. Removal of microorganisms from the
products,
II. Incubating of these microorganisms in the
suitable medium,
III. End of the incubation period, counting of
the microorganisms colony growth,
IV. Application of microbial bioburden
correction factor.
e product, it's microbial bioburden which is
known, is irradiated by specific radiation dose (such
as 5, 10, 25, 50 kGy). e remaining microorganisms
on the samples, aer irradiation is counted and
plotted to show the relation between radiation dose
and microbial death rate. According to the graphs, the
optimal irradiation dose is obtained showing this dose
appropriate to SAL 10-6 (Berk, 2002a).
In the radiation sterilization method, 25 kGy
irradiation dose is accepted for providing SAL at 10-
6. If there is no information about the number and
resistance of the microbial bioburden, the product has
to be irradiated with 25 kGy it means (Berk, 2002b).
Aer the sterilization of the syringes, some tests
are performed on solutions which are prepared from
the sterilized syringes, in order to check the sterility.
One of these tests is in vitro Limulus Amebosite
Lysate (LAL) method, which is applied for the control
of the existing pyrogens by using amebosite lysate,
which is obtained from Limulus Polyphemus. In this
method, endotoxins of gram negative bacteria and
amebosite lysate react under in vitro conditions. By
the results of this method, only endotoxins of gram-
negative bacteria are identified then other toxins,
which cause fever, can not be determined (Japenese
Pharmacopoeia, 2011c).
Other method is Growth Promotion Test. e
presence of microorganisms is checked in samples,
which are taken from the sterilized syringes with this
test. e samples are incubated in Soy Bean Casein
Digest Medium (SCDM) and Fluid ioglycolate
Medium (FTM) and kept throughout at least 14 days
at 30-35oC. At the end of the incubation period, media
are checked whether there is any growth of micro-
organisms or not. If there is no growth at media, it can
be concluded that the sterilization process is successful
and the syringes are sterile (Özer, 2005).
During the control of sterility, If the manufacturers
validate the sterilization process as indicated and keep
rules in the methodology of radiation dose selection,
it is possible that syringes are released without these
tests or quarantine period. ese rules are indicated in
ANSI/AAMI/ISO 11137-1994 "Sterilization of health
care products–Requirements for validation and routine
control–Radiation sterilization" by American National
Committee, that have been chosen from Association
for the Advancement of Medical Instrumentation
(AAMI) (Berk, 2002a).
For the validation of terminal sterilization method,
three processes are used (United States Pharmacopeia,
2006).
• Bioburden-based process
• Biological indicator/bioburden combined
process
• Overkill process
e bioburden-based process depends on the
33
FABAD J. Pharm. Sci., 41, 27-37, 2016
bioburden information of the product. Checking
critical control points, obtaining of the relation
between several radiation doses, bioburden counts
and radiation resistance are the crucial knowledge of
this method, especially, when the tight sterilization is
needed.
Biological indicator / bioburden combined
process shows the inactivation of microorganisms,
which are resistant to the sterilization process. Also,
this method is used when overkill process causes
possible loss at product's properties and in the EO
sterilization of syringes.
In order to benefit from overkill process product,
bioburden count and prevalence of spore forms in
the product should be known. is method can be
used when sterilizing agent and sterilization cycle
conditions don't aect the quality of product (United
States Pharmacopeia, 2006).
RADIATION EFFECTS on PLASTIC SYRINGES
Between 25-40 kGy radiation doses, some changes
can occur on the plastic syringe materials such as
decomposition, discoloration, formation of more
amorphous structure, chain scission, formation of
cross-linking bond in polymeric chains, increasing of
gas permeability. In these changes, the most important
one is the formation of radiolytic products.
ese changes are dependent on dose rate, dose
type, the type and crystallinity level of polymer, the
presence of additives and the method used (Fintzou et
al., 2007a, 2007b; Haji-Saeida et al., 2007). For example,
while cross-linking occurs in PE plastic material, PP is
sensitive to discoloration (Sastri, 2014). Also, dose rate
and the distance to the out surface cause the changes
of packaging material. e oxidative degradation in
plastic materials with e-beam is less than with gamma
radiation. Because, the exposure time to irradiation
is shorther than gamma sterilization (Fintzou et al. ,
2007a, 2007b; Haji-Saeida et al., 2007).
In order to obtain information about dierences
between non-irradiated and irradiated plastic
materials, several tests were performed as follows
(Fintzou et al., 2006):
• Mechanical testing (tensile strength,
percentage of elongation at break, compression
testing, tear strength, puncture resistance)
• Physicochemical testing (thermal testing)
• Colorimetry (the measurement of discoloration
degree)
• Fourier Transformation Infrared Spectroscopy
(FTIR) (the measurement of structural changes)
• Gas Chromatography- Mass Spectroscopy
(GC/MS) (the identification of radiolysis products)
• Electron Spin Resonance (ESR) (the
identification of radiolytic products)
• Rheological testing (the measurement of
molecular weight changes)
Fintzou et al. , (2007b) compared the eects of
e-beam and gamma rays on PP syringes. For this
purpose, they studied on non-irradiated and irradiated
at 30, 60, 120 kGy PP syringes. Gamma rays are
obtained from a source of 60Co and e-beam obtained
from a linear accelerator. Aer sterilization, they
exhibited some changes on PP syringes. Firstly, they
observed a decrease in the load at break and elongation
at break while increase in irradiation dose and also the
decrease at the gamma radiation sterilization which
was higher than e-beam sterilization. According to the
dierential scanning calorimetry test results, melting
enthalpy has decreased while irradiation dose has
increased for two methods which shows the polymers
had turned into more amorphous form due to the
eect of irradiation. Furthermore, they demonstrated
that the discoloration has been higher in the samples
which were irradiated with gamma rays and color of
these samples had turned into more yellow.
Fintzou et al. , (2007a) exhibited the eect of
e-beam on PP syringes at dierent radiation doses.
Depending on the results of mechanical tests, the
decrease was found in the load break while increase
in irradiation dose from 30 kGy to 120 kGy. In
accordance with dierential scanning calorimetry,
melting and fusion enthalpy decreased as increasing
irradiation dose. In order to understand alteration on
PP material's color, they measured color before and
aer irradiation at various doses and reported that
the color dierence increased with the increasing of
irradiation dose. In accordance with the results of FTIR
analysis, they showed that there have been formation
of aldehydes and ketones because of reaction between
oxygen molecules and free radicals. In order to define
radiolysis products which occurred at dierent
radiation doses, they applied GC-MS chromatography
and obtained some compounds such as 1,3-dichloro
2-propanone, 3,3,3-trichloro-2-methyl 1-propene, 3,4
dimethyl-phenol, 1,3 di-tert-butyl benzene, 4-tert-
butyl-2-chlorophenol at 30 kGy; outside of above
compounds 1,1,3 trichloro-2-pentanone, diisobutyl
phthalate and heptacosane at 60 and 120 kGy. Also
they indicated that at higher irradiation doses amount
of these radiolysis have been more.
Another study about gamma-irradiated
physicochemical and mechanical properties of PP
syringes was made by Fintzou et al. (2005). ey used
60Co sources for irradiation PP syringes at 30, 60 and
120 kGy doses. Aer irradiation they tested mechanical
properties of syringes, they observed that load at
break and elongation at break of syringes material
have decreased at higher irradiation doses. In order to
obtain information about the changes of melting and
crystallization behavior of PP syringes, they applied
DSC and obtained the melting temperature and fusion
enthalpy, which are connected with crystallinity, have
decreased as increasing irradiation dose. From the
results of color measurements, they also showed that
total dierences of color have increased at higher
radiation doses. According to FTIR analysis, they
observed that there have been a serious change at
1720 cm-1 in carbonyl band related to the formation of
free radicals. e radiolysis products were described
with GC-MS analysis and thirteen compounds
were identified for non-irradiated syringes, fieen
compounds for irradiated syringes at 30 kGy and
sixteen compounds for irradiated syringes at 60 and
120 kGy.
Abraham et al. (2010) made some studies for
showing the eects of e-beam radiation on physical
and chemical properties of PP syringe materials.
ey irradiated samples at 20,40,60 and 80 kGy doses
for 4 min individually. ey showed that strength,
elongation at break and viscosity had decreased with
the increase in radiation dose. Also, they indicated
melting point decreased at higher irradiation doses
depending on the results of DSC. In accordance with
ESR, they indicated that the radicals in PP syringes
had turned into another species and the short term
changes had occurred in the radicals type and
concentration in the first-two hours. In addition,
depending on the results of ESR, it was indicated that
the amount of radicals have increased during seven
days, but aer seven months any radicals have not
been found in the samples.
In the sterilization process, gamma radiation
eects on 3 types of PP syringes, which are
commercially available, were investigated. Aer
the sterilization, the properties of syringes (acidity
or alkalinity, absorbance, reducing agents, silicone
oil) have been found appropriate to the standards
as indicated in pharmacopeias. In addition, suitable
SAL doses for sterilization have been determined
and the samples, which have been prepared from
sterilized syringes with this dose, have been used
on the sterility and pyrogenicity tests. At the end of
these tests, growth and gelation have not occurred so,
these results showed that syringes could be sterilized
properly (Turker, 2009b).
In another study, eects of EO and gamma radiation
sterilization on 2 PP and 2 PE commercial syringes,
have been carried out. Sterility and gelation tests were
applied on the EO and gamma irradiation sterilized
samples, both. According to the results of these tests,
growth and gelation have not occurred. At the end of
the sterilization, syringes have been found suitable in
terms of appearance, acidity or alkalinity, absorbance,
reducing agents, silicone oil for the physicochemical
standards available in the pharmacopeias. In addition;
according to the results of mechanical tests, aer the
EO and gamma radiation sterilization maximum
strength, elastic modulus, elongation, molecular
structure have not changed in PP and PE syringes.
However, melting ow rate (MFR) values of syringes,
which are sterilized with EO, have not changed, MFR
values of 2 PP and 1 PE syringes, which are sterilized
with gamma radiation, have increased because of the
breaks in the polymer chains (Berk, 2002c).
POSSIBLE INTERACTION of SYRINGES and
CHEMICALS
Syringes are used at the administration,
transportation or storage of dierent types of solvents
and chemicals. As long as solvents and plastic syringe
materials contact with each other, the stability of
solutions can decay depending on plastic type,
solvent type, the manufacturing process. For instance
solvents may diuse to the plastic, the plastic may
extract to the solvent, undesirable products can occur.
Possible interaction between syringe materials and
solvents is very important. Because of the results of
these interactions, the integrity of plastic materials
may be lost, unwanted precipitate may occur. For
the aim of the evaluation of the chemical resistance
of plastic materials, ASTM D543 and ISO 4599 tests
are used. In accordance with these test procedures, at
least 5 samples, for each strain condition, chemicals,
materials and time, are prepared and they exposed
to the dierent solutions with suitable methods like
immersion, wipe, spray. At the end of this period,
changes in weight, possible hazing or cracks in
appearance, physical properties (such as tensile
strength and elongation) are evaluated and compared
with the control group (Sastri, 2014; Intertek Plastic
Technology Laboratories).
STABILIT Y STUDIES in the PLASTIC SYRINGES
In the literature, in order to show possible
interaction between some solvents or solutions and
plastic syringe materials some studies have been made.
Lewis et al. have investigated the possible
adsorption of atropine and ephedrine to plastic syringe
material. For this purpose, they kept atropine and
ephedrine solution in 3 plastic syringes and for control
group in 1 glass syringes during 4 days. Aerwards,
they have analyzed the samples with HPLC and have
35
FABAD J. Pharm. Sci., 41, 27-37, 2016
showed that there had been only 1.4 % reduction at
ephedrine sulfate concentration between the first
and the last day. On the other hand, they found that
the decrease in atropine sulfate concentration had
been 52 % at the end of fourth day. So according to
these results, they said that there have been possible
adsorption of atropine to plastic syringe (Lewis et al.
1994).
In order to understand the stability of heparin
sodium in plastic syringe materials, Tunbridge et
al. have diluted and stored heparin solution in PP
syringes and glass containers. According to partial
thromboplastin time (APTT) method, they found that
heparin activity had decreased considerably in glass
containers within 2 hours because of the absorption
of heparin to the glass surface. Also, they kept PP
syringes at 0-4oC and room temperature in the dark in
order to obtain information about the eect of storage
temperature. At the end of this study, they reached
that the storage time was more than three weeks and
there was an important decrease at heparin activity
(Tunbridge et al., 1981).
Stewart et al. (1992) investigated ceazidime's
stability in plastic syringes and glass vials under
dierent storage conditions. ey have kept PP plastic
syringes or glass vials containing ceazidime solutions
at dierent storage conditions. ey used HPLC for
the evaluation of ceazidime solution's concentration
and reached that ceazidime solution had been stable
in plastic syringes and glass material during 8 hour at
room temperature, 96 hour at 4oC and aer 28 and 91
days at -20oC. Also, they indicated that the number of
particulate matter is fitting to spesifications of USP for
small volume injections and the number of particulate
matter has not been changed during freezing and
thawing.
Hung et al. (1988) to check the stability of
morphine solution, they stored it at 3 and 22o C, with
and without antioxidant and preservative, in ligth and
dark in 2 types of plastic syringes at longer than 12
weeks. During the storage period, they investigated
the contaminants which is extracted to the solution
from syringe material and indicated that in 2 types
of syringes degradation of morphine have been less
than 3% in light at 22oC. Also, this value have been
found less in dark at 3oC. e results of reversed-
phase ion-pair HPLC with and without antioxidant or
preservative showed the morphine solution's shelf-life
is respectively 33 and 20 weeks in one type of plastic
syringe. In the other type of plastic syringe they found
that the shelf-life had been longer than 1 year.
Degradation of atracurium besylate injections in
plastic syringes have been investigated by Pramar et
al. ey have reached that there had been positive
eect of refrigeration on stability and also at room
temperature the atracurium besylate injections could
be stored up to 6 weeks (Pramar et al. 1996).
Nahata et al. (1992) have stored the plastic syringes
containing ceazidime (with arginine) in sterile water
at three dierent temperatures (22, 4, -20oC) at certain
time intervals. e solutions contacted with the inner
surface syringes were analyzed with HPLC to obtain
information about concentration of ceazidime, pH,
color changes and formation of any precipitate. When
the results were evaluated, the concentration has
remained the same, any precipitate has not occurred
but pH has decreased and the color of the solution has
changed from light straw to dark yellow.
Swanson et al. (2013) have studied adsorption of
99mTc-sestamibi radiopharmaceutical, which is used
common in cardiac imaging at nuclear medicine, to
6 dierent brands of plastic syringes, which are used
in hospital practice. ey indicated that the main
reason of adsorption was lubricant, used in the inside
of the syringe barrel. In addition, they showed that
the residual activity in syringes have been 22±8%
and 11±4% in barrel of syringe, 9±5% of the residual
activity have been in syringe plunger, 1% of the
residual activity in the needle and the cap of syringe
and 1% of the residual activity in the scalp vein set.
Also, any relation between volume of injection and
the residual activity could not be found.
Keskintepe et al. (2005) have studied residual
radioactivity with various 99mTc kits, which are used
in nuclear medicine, in 2 dierent commercial plastic
syringes. ey reached that the residual radioactivity
had been less in rubber ending syringe because of
little void volume. In addition, when the volume of
solution has increased 2 times, amount of radioactivity
has decreased significantly in 2 types of syringes.
In 99m Tc-Mikroagregat Albumin (99m Tc-MAA)
radiopharmaceutical used in pulmonary imaging, the
residual radioactivity have been found higher than
other kits because of the colloidal dispersion structure.
CONCLUSION
Plastic syringes, which are classified as Class IA
medical devices, are one of the most important medical
devices for the purpose of administration drugs into
the body by parenteral route. Because of widespread
use of them some requirements are designated on the
national and international basis and resulting several
standards are obligatory from quality point of view
and therefore the materials used in the production of
plastic syringes must be at medical grade.
To be sterile is one of these requirements.
Sterilization can be applied by radiation (gamma
36
Karpuz, Özer
or e-beam), EO or heat (autoclave, oven). Owing to
superiority of irradiation, this method is preferred
commonly. But, while gamma or e-beam rays use for
sterilization, possible changes in plastic material has
to be considered.
On the other hand, possible interaction between
plastic syringe materials and administered drugs with
syringe is another important issue and this interaction
is depending on the solvent type, plastic type and
manufacturing process.
As a result, hypodermic syringes which are the
most frequent used ones and made of PP or PE,
take place under the umbrella of Class IA medical
devices. ey have to own several properties indicated
in pharmacopeias, suitable process of production
indicated in standards (TS EN ISO 7886-1, TS EN
ISO 7886-2, TS EN ISO 7886-4) and pass the tests
(Mechanical test, Physicochemical test, Colorimeter,
Fourier Transformation Infrared Spectroscopy (FTIR),
Gas Chromatography/ Mass Spectroscopy (GC/MS),
Electron Spin Resonance (ESR), Rheological test)
which are applied to plastic material aer the radiation
sterilization.
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... Since the natures of such medical grade plastics are specialized due to its high heat resistance, more durable, impact strength and highly stable under UV irradiation, there may have impact on the yield of liquid fraction from thermal treatment. Likewise, these outstanding properties of medical-grade plastics contain various additives, plasticizers, slip and curing agent etc. that may influence the characteristics of the thermally cracking fuel oil 34 . Moreover, disposable medical-based plastic wastes are disposed of every day from the hospitals, clinics and the diagnostic centres, which perform as a vector of spreading of communication diseases. ...
The present work is an effort to produce liquid fuel oil from plastic based medical wastes through thermal cracking process under oxidizing conditions. The mixed plastics from medical wastes were considered as a feedstock, shredded into small pieces and heated at 773 ± 10 K for 40 min with a heating rate of 20 K/min in a batch reactor for thermal cracking process. The feedstock was characterized by proximate and ultimate analysis along with thermogravimetric investigation. Moreover, chemical compositions of the liquid fuel oil were examined by FTIR and GC–MS spectroscopy. The properties of liquid product were also examined and compared to the commercial fuel oil. The average yield of brownish and sticky liquid fuel was obtained to be 52 wt% and the gross calorific value of the liquid was found 41.32 MJ/kg which is comparable to that of commercial diesel. FTIR spectrum showed characteristic absorption bands of C–H and =CH 2 groups indicating presence of alkane and alkene compounds. GC–MS study demonstrated the chemical constituents of the liquid product that is mostly aliphatic compounds of mainly alkanes (16.28%), alkenes (10.67%), alcohols (14.65%) and ester groups (10.38%) including iso-phthalate (40.02%) as a predominant product. This experiment concludes that the liquid oil derived from thermal cracking of mixed plastics comprised of a composite mixture of organic components. A significant amount of non-degraded constituents like plasticizers, precursors, etc. remained in the product having some economic values with human health and environmental impacts during burning has been addressed in the current issue.
... In relation to the syringes, although it has not been reported in the literature on a similar study with ozone gas, this result leads to consider the ozone penetration capacity in materials made of polypropylene, even in worst case situations, such as the simulated with the syringes and their respective cap, which would hamper the access of the gas to the inside of them, similar the sterilization of products in the terminal packages by ethylene oxide process [36]. ...
Purpose: Ozone (O3) can be considered the most potent natural germicide against microorganisms (in vegetative and spore forms) with high efficiency and speed, because of its highly oxidizing activity. Despite this, there are a few studies describing the application of ozone as a sterilizing agent of medical devices. The aim of this communication was to describe the development and validation of a sterilization cycle applied to medical devices. Methods: The sterilization process was challenged using Geobacillus stearothermophilus ATCC 7953 spores, which have shown great resistance. The sterilizing effect of ozone was measured using carriers inoculated with 106 CFU/mL spores, introduced into a 3-mL syringe and lumens of tubes of different sizes and diameters simulating hospital medical products, which have undergone a half-cycle or complete cycle. Results: The results of sterilization process studied in active vegetative form of microorganisms showed that the ozone sterilization was effective with a bioburden between 105 to 107 CFU/mL with one pulse sterilizing action. The validation of the process was confirmed by the satisfactory results for the half-cycle, corresponding to a treatment with four pulses allowed sterilizing the material with bioburdens < 106 CFU/mL spores which indicate an appropriate sterility assurance level. Conclusion: The results showed that the ozone may be considered as effective and promising alternative for sterilization of thermosensitive materials and medical devices.
- Dilek Keskintepe
-
![Yekta A Ozer]()
Both syringe type as well as the volume of the patient doses of radiopharmaceuticals can cause high residual activity in the syringes during application to patients. Therefore, we aimed to investigate the effects of syringe type and differences in volume and personnel on residual activity and adsorption. Injection of radiopharmaceuticals needs special attention. We concluded that less care during injection or preparation of the radiopharmaceutical in syringes will lead to a decrease in the accuracy of radioactive dose received by the patient and to an increase in environmental contamination due to the residual radioactivity in the syringes.
The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly covered with the designed chemical composition. A microflow imaging analysis showed that the SOF system drastically reduced both silicone oil (SO) doplets and oil-induced aggregations in a model protein formulation, whereas a large number of subvisible particles and protein aggregations were formed when a SO system was used. Satisfactory container closure integrity (CCI) was confirmed by means of dye and microorganism penetration studies. Furthermore, no significant difference between the break loose and gliding forces was observed in the former, and stability studies revealed that the SOF system could perfectly show the aging independence in break loose force observed in the SO system. The results suggest that the introduced novel SOF system has a great potential and represents an alternative that can achieve very low subvisible particles, secure CCI, and the absence of a break loose force. In particular, no risk of SO-induced aggregation can bring additional value in the highly sensitive biotech drug market. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci
- Vinny R. Sastri
Plastics used in medical device applications must meet stringent performance requirements through production, packaging, shipping, end use, and disposal. Many devices and device kits are sterilized before they are shipped for use. During manufacturing and during end use they also come in contact with various chemicals, solvents, bodily fluids, skin, organs, and tissues. The materials used in such devices must be resistant to the sterilization methods, chemicals, and fluids that they encounter, be compatible with bodily fluids, skin, and tissues, and still maintain their safety, effectiveness, and functionality. Requirements for plastics used in medical devices include the following: 1. Material characterization, 2. Sterilization resistance, 3. Chemical and lipid resistance, 4. Extractables and leachables characterization, 5. Biocompatibility and hemocompatiblity, and 6. Shelf life and stability. Many devices need to be packaged and sterilized either before distribution or before use. Examples of such devices are exam and surgical gloves, clean room garments, specimen cups, wound care products, sutures, needles, syringes, catheters, drain bags, IV bags, fluid delivery systems, dialysis equipment, implants, surgical instruments, dental instruments, surgery supplies, and combination products. All materials used in such medical devices, including the plastics used in them, must be capable of being sterilized without loss of performance.
Silk fibroin has been widely explored for many biomedical applications, due to its biocompatibility and biodegradability. Sterilization is a fundamental step in biomaterials processing and it must not jeopardize the functionality of medical devices. The aim of this study was to analyze the influence of different sterilization methods in the physical, chemical, and biological characteristics of dense and porous silk fibroin membranes. Silk fibroin membranes were treated by several procedures: immersion in 70% ethanol solution, ultraviolet radiation, autoclave, ethylene oxide, and gamma radiation, and were analyzed by scanning electron microscopy, Fourier-transformed infrared spectroscopy (FTIR), X-ray diffraction, tensile strength and in vitro cytotoxicity to Chinese hamster ovary cells. The results indicated that the sterilization methods did not cause perceivable morphological changes in the membranes and the membranes were not toxic to cells. The sterilization methods that used organic solvent or an increased humidity and/or temperature (70% ethanol, autoclave, and ethylene oxide) increased the silk II content in the membranes: the dense membranes became more brittle, while the porous membranes showed increased strength at break. Membranes that underwent sterilization by UV and gamma radiation presented properties similar to the nonsterilized membranes, mainly for tensile strength and FTIR results. © 2013 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2013.
- Tiffinee N. Swanson
- Duong T Troung
- Andrew Paulsen
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![Michael K O'Connor]()
The purpose of this study was to document the extent of adhesion of (99m)Tc-sestamibi to syringes in patient procedures, determine factors that influence the degree of adhesion, and evaluate alternatives to our current practice that would either result in a more reproducible degree of adhesion or, ideally, eliminate adhesion. The extent of adhesion was documented in 216 patient procedures and evaluated in detail in an additional 73 patient procedures. We evaluated the nature of the adhesion and its possible causes, including the location of adhesion in injection sets, the effect of syringe type, and the effect of prerinsing of syringes with various solutions of nonradiolabeled sestamibi and (99m)Tc-sestamibi. The extent of adhesion was reevaluated in 50 procedures performed using the syringe type that demonstrated the lowest adhesion rate. The degree of adhesion of (99m)Tc-sestamibi to the injection set was found to be 20.1% ± 8.0%, with a range (10th-90th percentiles) of 9%-31%. The primary cause of adhesion appeared to be the lubricant used inside the syringe barrel. Evaluation of 6 different syringe types identified a brand with a lower adhesion rate. Reevaluation in patient procedures using this brand showed a 5.2% ± 2.5% degree of adhesion, with a range (10th-90th percentiles) of 2.5%-7.7%. Selection of the appropriate type of syringe can significantly reduce the magnitude and variability of residual (99m)Tc-sestamibi activity. With more reproducible residual activities, we have been able to achieve an approximately 20% reduction in the dispensed dose of (99m)Tc-sestamibi used in clinical procedures and a more consistent injected dose with less interpatient variation. The frequent changes in syringe design by manufacturers require that a quality control program for monitoring of residual activity be incorporated into clinical practice. This program has allowed us to maintain image quality and achieve more consistent injected patient doses in clinical procedures that use (99m)Tc-sestamibi.
Mechanical, thermal, chemical decomposition and electron spin resonance (ESR) methods were used to study electron beam irradiated polypropylene syringe barrels that were irradiated to a total fractionated dose of 0, 20, 40, 60, and 80kGy (in steps of 20kGy). Dose mapping was conducted to determine dose to and through the syringe barrel. Analysis of these data indicated that degradation of the polypropylene syringes increased with an increase in electron beam irradiation.
In the present study, the effect of electron-beam irradiation on physicochemical and mechanical properties of polypropylene (PP) syringes was studied. Three irradiation doses (30, 60 and 120kGy) were applied to all samples. Non-irradiated PP syringes were used as control samples. Electron-beam irradiation caused an increase in the degree of yellowness and in the extractable radiolysis products. A decrease in compression strength and extension at break was the result of electron-beam irradiation on mechanical properties of PP syringes. Minor differences were observed in FTIR spectra, mainly in the region of 1720cm−1, corresponding to the absorption of carbonyl compounds. Gas chromatography/mass spectrometry (GC/MS) analysis indicated the formation of a number of radiolysis compounds while a number of compounds initially present in non-irradiated syringes were destroyed by the irradiation. The degradation on polymer properties caused by electron-beam irradiation was less severe than that caused by gamma irradiation.
The effect of electron-beam and gamma irradiation under vacuum on the physicochemical and mechanical properties of commercial polypropylene (PP) syringes was studied. Irradiation doses of 30, 60 and 120 kGy were used while for comparison purposes respective non-irradiated (control) PP syringes were also studied. Mechanical tests, differential scanning calorimetry analysis, color determination and FTIR were carried out to evaluate the effect of both irradiation treatments (electron-beam and gamma irradiation) on PP syringes. Both compression strength and % extension at break decreased with increasing irradiation dose. Melting temperature as well as specific melting enthalpy also decreased while the degree of yellowness increased with increasing irradiation dose. Minor differences in FTIR spectra were observed after irradiation treatment.
Source: https://www.researchgate.net/publication/315584108_Syringes_As_Medical_Devices
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