We collected wfi in pressure vessel and cool down at 60 degree centigrade.scdm added and filtered in 2 filling vessel.each vessel contained approx 20 liter solution.all filled vials were clear till 2 hour filling process.after 2 hour ,we observed black particles and haziness in filled vial.equipment cleaning and filter were ok. Vials ,rubber stopper and environmental monitoring were also ok. What may be root cause for it.
Filled vials with black particles were passed in sterility test.
kindly explan the reason.
Possible ans may be due to growth but acc to u sterility test is ok.Effect of Temperature?
Filling machine proper cleaning ?
transfer pipes cleaning?
Yes it was effect of temperature. Pressure vessel and filling vessel were non jacketed.so black particles generated in solution due to charring . When we opened the filling vessel we found charring media in inner surface of filling vessel.media fill solution was stored in closed container at 60 degree so it burnt after 2 hour exposure time.
now how to resolve this problem?
mean by using steam jacket?
Collect the wfi in jacketed pressure vessel .Cool down the wfi at 60 degree centigrade.add the SCDM and dissolve it.then cool the solution up to 25 degree centigrade with help of hot and cool system . Filter the solution and collect in filling vessel.
why we add SCDM in wfi?
to validate our system or?
Media fill is performed to check whether our equipment, process, system, personnel are adequate to produce a product aseptically.
SCDM is added in wfi as growth media. 3% SCDM solution is used for media fill simulation.
comercially what is the use of bacteriostatic
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection.
preservative testing in fineshed form of sterile products is required?
Testing for antimicrobial preservative content should normally be performed at release. Under certain circumstances, in-process testing
may suffice in lieu of release testing, where permitted. When antimicrobial preservative content testing is performed as an in-process test, the acceptance criteria should remain part of the specification.Antimicrobial preservative effectiveness should be demonstrated
during development, during scaleup, and throughout the shelf life.
single dose sterile products does not contain preservatives?
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection.Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.
In case of emergency alarm e.g earth quake etc what is the procedure of exit from sterile area?
Emergency exit door is used to go out side production area.red color painted door is used for emergency exit door.
i want to ask about machine shut down n degowning etc.
will have to follow protocols or not?
Power shut down should be done to prevent short circuit.