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Sunday, March 22, 2009

Rubber closure Injectable preparation rubber closers evaluation tests requirements

Rubber closure for Injectable preparation how rubber closers are evaluated for the use in injectables
Dear friends , in last post i had provided information on containers for injectable preparation , and the constitution of containers for injectable , as i want to make this blog as a complete guide for pharmaceuticals manufacturing pharmacists as well as pharmaceutical or pharmacy too.

Closers in injectable preparations are components which comes in direct in contact with the preparation and drug, hence it requires to comply with some spacial requirements for sterility as well as drug compatibility etc which i am going to disscuse today here .
Rubber closures may be synthetic or from natural origin , it is generaly a complex mixture of many ingredients like polymer fibers ,vulcanising agents , accelerators and stabilizers , pigments
The properties of closers for injection are dependant on the composition of this additives as well as methods of preparation. it is important to chose these ingredients property as they come directly with injectable preparation , which is going to be injected directly in to body .
Hence closures are evaluated for for its suitability by performing some tests on them.
Before choosing a closure for injectable preparation for any particular formulation it should be tested for its compatibility with that preparation separately and independently with respect to absorption , adsorption and other phenomenons which are associated with closures evaluations so as to ensure complete compliance of standards for closure for injectable preparation.
Any proposed change in composition should again be evaluated .
I am giving in brief what are those tests and procedures for caring these tests in brief .
First we need to prepare a sample for testing the closures effectiveness and compliance with all standards.
Wash the closure by agitating in 0.2 % solution of a anionic surface active agent for 5 mins at RT .
Rins 3 times with water , put the washed closure in a suitable container of type 1 or a borosilicate glass and autoclave at 121 °C to for 30 mins. volume of water keeping about 5 times more than tat of volume of closures, after autoclaving dry them in vacuum at 65°C for 24 hrs.
Now we should perform following tests
1.Sterilisation test
2.Fragmentation test
3.Self Sealability tests.
4 Extractable matter.
a.Appearance of extract
b.Reducing substances
c.light transmission at 620 nm
d.Test for Heavy metal
e.total Ash
f.Test for loss of preservative
This is evaluated by placing a known qty of phenol , for given temperature and conditions and loss of phenol is estimated by caring out a back titration using iodometric titration for estimation of phenol.
These all test you have choice to chose from USP or BP.
There these test are given in detail procedure.

1 comment:

Anonymous said...

plz send me the details on this topic as well as formulation guidlines for injections.
Mail ID - jairam_kulkarni@yahoo.co.in

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