Regarding line Clearance

TEMPLATES & PRESENTATIONS
1

Dear All,

I am having a query regarding Bung processor cum steam sterilizer:

  1. Do we have to take line clearance for an equipment whenever we are runnnig equipment for a particlar process or a batch ?

  2. If we are manufacturing two baches on same day and for those two batches we are using same lot of washed & sterilized Rubber stoppers and same lot for Component preparation, then for batch which is being manufactured afterwards how do we take line clearnce for Bung processor cum steam sterilizer ?

2

  1. When ever you use any equipment for component preperation or any processing in pharmaceutical industry it is necessary and manadatory to take a line clearence from QA. The main issues here are un used materials on or in the machines, when it was cleaned, status if it is unloaded or loaded in full capacity and also log controls of machines.Once it is fully cleaned after checking the staisfactory controls QA will give line clearence. This is a clear procedure to avoid mix up in any process or processes.

  2. Only once the line clearence will be given. But in this case the Sterility assurance will be questionable.If you are using a washing cum bung processing machine for 2 lots of same production batch it is always risky to take some bungs out and leave remaining in a bung container or even some in bung processing machine.Once processor is opened the whole bunch of stoppers will be exposed to envirnonment in sterile areas. If there is a failure or stoppage of the earlier batch,until that line is cleaned you cannot start a fresh lot.

This process involves its own risks.Pharmaceutical companies think to carry processes economically in one shot or they might have purchased a bigger bung cum sterilizer.Its not wise if you do not have enough controls in place.

3

Thanks for your reply Sir, but i want to know 1) Do we have to take line clearance of bung processor whenever we are running the equipment for a single batch or process?
2) If we are manufacturing two bacthes in single shift /day and both batches using same lot of rubber stoppers & filling assembly parts how do we take the line clearance of the equipment for the batch being manufactured afterwards ?

4

When ever you start an operation you must and should take a line clearence.Any process, equipment should start with a approved LINE CLEARENCE FORM.

Regarding your second question: It is confusing. Let us start with basics

Every batch has a BMR

Every batch is having a Batch number

Every time you give a line clearence you need to record in your BMR.

Now let me ask you how can you give same line clearence for different batches which has same time, same QA person, Same shift operator , same manufacturing chemist with different batch numbers?

I think your procedure is wrong.

As per regulatory guidelines all the sterile components must and should be prepared as per batch capacity. If you do not do so the second batch will be at risk of losing its sterility by using components that were pre used in aseptic area or already opened before any batch preperation begins in aseptic area.

" The essence of Line clearence is removal of all items from previous batches, contaminated substances or waste materials or un used materials either existing or from previous batches so that the equipments are cleaned properly and they are ready to perform their intended operation as per GMP and Validated procedures".

“If line clearence is not proper or same line clearence is given for 2 manufacturuing batches with different batch numbers the process is at stake or in trouble.”

These are very basics of GMP-- I hope you ought to get a GMP training at your facility.

5

Excellent reply Sir, I knew this very thing but our organization used to follow this procedure for two batches of same product being manufactured in a single day/shift.

thanks for your reply…