Author Topic: Media Fill Trials  (Read 1765 times)

Pravin Palekar

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  • City: Pune
  • Organisation: Serum Institute Of India Ltd
Media Fill Trials
« on: November 08, 2012, 07:05:42 AM »
We have a combination filling line which can fill ampoules & vials.  On this line we aseptically fill 5ml Ampoules and 4ml Vials.

We perform media fill simulations once in 6 months. We feel that on a routine basis if we cover the Ampoule once and the vial once in a year, ensuring that the 2 runs are 6 months apart, this is adequate.

What are the views of the forum on this frequency of aseptic simulation given that the container type is different?

ONKAR NATH SINGH

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  • Organisation: Aristo Pharmaceuticals Pvt Limited
Re: Media Fill Trials
« Reply #1 on: November 09, 2012, 12:27:30 PM »
Reuqirement is 3 consequtive successful cycles on new commissioned line and after any major modification in the facility, which can effect performance of the aseptic process. There after once/Year. If you do so you meet the requirements.
O.N.SINGH

sainathgadam

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Re: Media Fill Trials
« Reply #2 on: December 10, 2012, 06:27:26 AM »
Dear Pravin,

You need to asses the impact for change process for ampule to vial i.e. container closure change and accordingly need to document Risk assessment based on the configuration of your machine as specified in the section IX under A Process simulation sr. no. 02 Frequency and Number of Runs from the USFDA guideline for Sterile Drug Products (Sep. 2004).

Its all depends on the actual mechanism that works for the dual line (Vial and ampule), also consider that the container closure system is also changing.

regards,
Sainath Gadam
Sainath Gadam

Durga Prasad

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Re: Media Fill Trials
« Reply #3 on: December 10, 2012, 01:31:07 PM »
Before you change any frequencies you need to look into your batch records.
What I mean to say is that your BMR and BPR associated with your product/Batch release documents speaks volumes about your Sterility Assurance levels.
You can observe while you review the settle plates, dabs and swabs from your Personnel/ Equipments/Areas and operations.
You know better how your facility is behaving with respect to Sterility Assurance Procedures you implement in your facility.
Your media filling is just a part or tip of ice burg of the sterility procedures or manipulations you take care of.

With out proper documentation and risk assessment you cannot shift your Media fill schedules.

I politely disagree with Mr.Sainath comments.
The impact assessment is the primary requisite that was already considered during the selection and installation of machine. This is a part of pre and post Design Qualifications. (DQ).
All you need to know about your sterility assurance levels while you perform your operations and interventions in realtime.

Your BMR/BPR speaks volumes about failures and areas associated with failures.
First you need to address them. After correcting you need to address shifting of the media fill schedules.
If you shift schedules with out a proper scientific knowledge and justification, you will be lost for ever finding the root cause of sterility failures.

bharatbuk

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Re: Media Fill Trials
« Reply #4 on: February 02, 2013, 03:42:14 AM »
Before you change any frequencies you need to look into your batch records.
What I mean to say is that your BMR and BPR associated with your product/Batch release documents speaks volumes about your Sterility Assurance levels.
You can observe while you review the settle plates, dabs and swabs from your Personnel/ Equipments/Areas and operations.
You know better how your facility is behaving with respect to Sterility Assurance Procedures you implement in your facility.
Your media filling is just a part or tip of ice burg of the sterility procedures or manipulations you take care of.

With out proper documentation and risk assessment you cannot shift your Media fill schedules.

I politely disagree with Mr.Sainath comments.
The impact assessment is the primary requisite that was already considered during the selection and installation of machine. This is a part of pre and post Design Qualifications. (DQ).
All you need to know about your sterility assurance levels while you perform your operations and interventions in realtime.

Your BMR/BPR speaks volumes about failures and areas associated with failures.
First you need to address them. After correcting you need to address shifting of the media fill schedules.
If you shift schedules with out a proper scientific knowledge and justification, you will be lost for ever finding the root cause of sterility failures.
this advice need to be followed , because finding root cause is very important, this is the key of success and is necessary for every field.

 


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