Freezers Qualification

GOOD ENGINEERING PRACTICE (cGEP)
1

Hello,

We have some freezers in our production site used to keep laboratory standarts and blood plasma.
what are the regulatory requirements regarding freezers qualificaion if any.
what is the practical approach regarding this subject ?

Thanks,
moshe.

2

Dear Moshes,

I think method of freezer qualification is similar to incubabator qualification.
You must do the temperature distribution test esspecially in critical point (the drainage, near the door) so you know the temperature range of your freezer, then check with your requirement.
Some also do open - door test that shows the effect of opening door to the temperature. It depends on you to set 5 or 10 minute to simulate it.

May you can read this book, Pharmaceutical Process Validation.
Hope this information can help you.

Regards,

Felisia

3

[quote=Moshes]Hello,

We have some freezers in our production site used to keep laboratory standarts and blood plasma.
what are the regulatory requirements regarding freezers qualificaion if any.
what is the practical approach regarding this subject ?

Thanks,
moshe.[/quote]

To evaluate the performance of deep freezer three types of study must be designed.

  1. Continuous Monitoring for 72 Hours (with indepndent external temperature loggers)
  2. Power failure Test
  3. Door Opening/Closing Test (time establishment)

Regards,

4

Dear Moshes,

In addition to tests specified by Shahnawaz (very good) concerning the temperature you must regard the temperature specification of the products kept inside the freezer. Usually the pharamacopeia or the company internal documentation specifies that.
For example, I have a raw material that needs to be kept at -18ºC, according to the pharmacopeia. That´s my requirement.

Hope it helps

5

[quote=marcos 38]Dear Moshes,

In addition to tests specified by Shahnawaz (very good) concerning the temperature you must regard the temperature specification of the products kept inside the freezer. Usually the pharamacopeia or the company internal documentation specifies that.
For example, I have a raw material that needs to be kept at -18ºC, according to the pharmacopeia. That´s my requirement.

Hope it helps[/quote]

Dear Sir,
Please let me know for freezer validation minimum and maximum temperature should be validated or maximum temperature is sufficient.