Hello,
I need to validate a hold time, between the finish of the product preparation and the sterilizing filtration. Can anyone help me with the aceptance criteria, methods, etc.
Best regards
Javier
Holdtime validation of parenteral products includes risk factors.During some break downs you must either store the prepared product and also Filtered product in clod rooms.Then this must also be considered.You must consider the integrity of holding tank which holds your filtered product and also conduct study up to what maximum time it can hold the product sterile (Maximum period must be 10-12 hours-Overnight we may say).
You must first record all your product attributes and then start your study.Rate of preparation, Conditions of Hold,Tightness of your hold tank, Filtration Vessels ,Leak tests of filtration vessels,Rate of filtration, Integrity of Filter (pre & Post use integrity) Etc etc.
For Example when you prepare Heparin injection if you want to fill it next day due to any problems in filling line or any other reason , you must keep the manufactured solution at 2-8C. This is for both prepared and also filtered solution. In this case the coldroom will also come into study.
This padigram changes from product to product-- Samll volume parenterals
Lyophilised product- These products are first made into solutions and then they are filled and Lyophilized–Both Chemical, Synhetic Biological & Recombinant Therapeutic proteins.
Biological Products and Vaccines too(Vaccines are held for incubation after adjuvient is added along with Buffer+ Preservative(Thiomersal) + antigen).
All the above cited eaxmples follow almost similar path during their entire process or any one of their intermittent processes.These are all parenterals no matter what they are .Be it Chemical products, Synthetic Peptides or Natural-Recombinant Biological products.
[b][COLOR=“blue”] Hold Time Examples in Aseptic Processing
-Storage of Sterilized Stoppers
-Storage of Depyrogenated Vials/Ampoules in the Cooling Zone of Tunnel.
-Time between sterile tank SIP and Sterile filtration of Solution.
-Time bewteen Filling Line SIP and Start of Filling.
-Start to end of Filling.
-Freeze dryer duration.
-Freeze dryer loading to Capping(Sealing)/ Capping operation in liquid vials.[/color][/b]
Regards
Can anyone tell me about the process follow to be followed for the HOLD TIME STUDY for sterilised media to define the valid date for usage after media preparation?
The whole study depends on factors like:[b][COLOR=“blue”]
1.What is type of media? Complex or Defined?
2.What is media used for? Microbial analysis or Fermentation?
3.Is it Natural organism or Recombinant?
4.Is this in a petri dish or RODAC or Shake flask or Fermentor?
5.What is incubation temerature?
6.What are conditions of making the media?
7.Is this sterilised in a lab autoclave or Big Production autoclave or Fermentor?
8.Conditions to sterilize-Temperature max used and time?
9.Specific unloading and cooling conditions?
10.Specific pourplate techniques or Inoculating in a fermentor?
11.Type of Environment whole process is done–Under LAF or with in a Fermentor?
13.Time required to cool and solidification if Nutrient agar?
14. Type of sterilization of Utensils or Petridishes ?[/color][/b]
I know a guy who hold the filtret solution for 48 days and sterility passesd!!
Can someone help me in the following:
What types of tests is required when doing Bulk Holding Time Studies on Tablets and Capsules?
What limits must be applied to these tests (Stability or Release Limits)?
How many batches is required when doing these Hold Time Studies?
What amount of tablets/capsules is required to do a Bulk Holding Time Study?
What should the main points be for a Bulk Holding Time Study protocol (Basic structure/outline)?
Note: The Bulk Holding Time study (Tablets and Capsules) I’m referring to is when bulk product was manufactured and is ready for packaging.
Mr Prasad, thanks for your help.
Best regards
Dear All,
The tests for Bulk hold Time study mainly includes the parameters which can affect the quality i.e. Loss On Drying,Description, Microbial limit test in case of the products which have such ingrdients.
The limits should be spplied are for FPs.
Generally one batch is sufficient for the study.
Amoint of tablets can be calculated based on the tests to be performed.
Structure of protocol: Objective, Scope, Resosnsibility, Procedure, Sampling criteria, Acceptance limits, Frequency for sampling, Storage conditions etc.
Thanks and Regards,
MUEKSH VARDE
QUOTE=Odracir;13593]Can someone help me in the following:
What types of tests is required when doing Bulk Holding Time Studies on Tablets and Capsules?
What limits must be applied to these tests (Stability or Release Limits)?
How many batches is required when doing these Hold Time Studies?
What amount of tablets/capsules is required to do a Bulk Holding Time Study?
What should the main points be for a Bulk Holding Time Study protocol (Basic structure/outline)?
Note: The Bulk Holding Time study (Tablets and Capsules) I’m referring to is when bulk product was manufactured and is ready for packaging.[/quote]
You can hold for 72 hours.But technically speaking you must use with in 24 hours of sterilization.Processing sterile equipemnts or components with in 12 hours of sterilization is best practice in Industry.
Dear Javier,
Please go through the following site for the same.
Best regards,
Ankur
[quote=javier]Hello,
I need to validate a hold time, between the finish of the product preparation and the sterilizing filtration. Can anyone help me with the aceptance criteria, methods, etc.
Best regards
Javier[/quote]