MTS Cryo Stores provides a cGMP compliant validation package for various temperature requirements for controlled cabinets. From a single shelf to a full storage cabinet throughout our range of storage temperatures. We supply the standard validation required for this industry using the latest technology.

MTS Cryo Stores offers the following:

  • Temperature mapping
  • Validation (IQ,OQ and PQ)

     

After the mapping and validation has been performed, a clear summary of results will be provided in the form a report including detailed tabular data for your records.

All the equipment used is routinely calibrated, the data logging equipment and reporting sotfware is 21 CFR 11 complient and suitable for cGMP and GLP applications.

Non validated cabinets

Of course there are many customers who do not need the extensive validation program but still want to be asssured that the freezer is operating within its expected range and calibrated against UKAS standards. This is achieved by our engineers as part of our comprehensive maintenance program, with the provision of a standard calibration certificate.

The quality of the equipment is the same throughout the facility, but for the standard cabinets does not carry the additional comprehensive validation package.