Thermal mapping

GOOD VALIDATION PRACTICE (cGVP)
1

I am qualifying a freezer/fridge for IOQ/PQ.

I am use to performing the following:

24 hour empty study for OQ
72 hour loaded study for OQ

24 hour loaded study with actual product for PQ

For this new company, the past validation have been the following:

24 hour empty study for OQ
24 hour loaded for PQ

What is the requirement for OQ and PQ for temperature-controlled storage equiment?

2

I dont know if there are actual requirements stated anywhere on mapping. Our company does 72 hours empty at min temp, 24 hours empty at max temp, then 72 hours loaded at max temp and 24 hours loaded at min. It is all part of the OQ, there is no separate PQ.

3

I have to map a room for temp & RH conditions, can any one let me know about the no. of locations for mapping & any ref guidelines for this.

4

I did not hear any federal guidelines of this sort of temeperature mapping for clean rooms. There are clear guidelines for Cold wear houses.

You should know temperature and humidity of your room on day to day basis at all 4 corners and near the equipment you are operating.They must be recorded in log sheets and also Equipment log sheets and Batch Manufacturing records. Its a clear GMP guideline.

All these temp & RH measuring equipments must be calibrated and calibration log sheets must be maintained daily and they should be inline with SOP.

Regards

5

Control of process parameters (such as temperature, vacuum and time), and equipment operating performance must be challenged carefully. It is also important to understand factors unique to each Freeze dryer; e.g. the vial’s position on the Freeze dryer shelf may have an impact on product quality and batch uniformity.

Following Installation Qualification (IQ) and Operational Qualification (OQ), a complete Performance Qualification (PQ) must be done by thermal mapping. Comprehensive PQ guarantees a production and a process fully reliable, and gives the assurance of the highest product quality and batch uniformity.

Product mapping represents valuable data for process understanding. Temperature recorded via thermocouples placed inside vials filled with product, positioned at specific (worst case) location on shelves. A 24 to 72 hour loaded study with vials must be performed.

6

Hi All,

Well, A good discussion on Temperature / Thermal Mapping is going on. Would like to add few words.

  1. All critical systems required IQ, OQ & PQ [Basic GMP]
  2. As name it self suggested, Operational qualification should have the operational verifications of system under qualification and on the same way for PQ too.

There are no clear guidance for mapping technique, however one should assess & evaluate the criticality & design the study.

Basics for mapping :

  1. Whole area get covered by no. of probes [Thermocouples]
  2. Probe placement positions should be scientific rationale based.
  3. Study time & interval should be adequate to cater the magnitude of day & night.
  4. Seasonal variation must considered as crucial part of qualification.
  5. Identified hot / cold points must be incorporated for routine monitoring.
  6. Periodic re-evaluation is also required.

Happy Reading !