Validation

Equipment validation by our own team

tcps validates the equipment it supplies with its own validation team. During qualification we demonstrate, against pre-established requirements and your URS where available, that a device, system or instrument performs as specified. We provide both the qualification documents and their execution.

What we qualify

• Installation Qualification (IQ): the equipment is correctly installed, identified and documented.
• Operational Qualification (OQ): functions and alarms work within the specified operating ranges.
• Performance Qualification (PQ): the equipment performs as required under your actual working conditions.

Isolator qualification

For hospital pharmacies and pharmaceutical companies we qualify and requalify isolators, including the hydrogen peroxide (H₂O₂) biodecontamination cycles of the isolator and its transfer hatches, tested with biological indicators. We also support change control, for example when a decontamination agent is replaced: a risk based qualification plan that keeps the number of test runs to a minimum without losing evidence.

Standards and guidelines we work with

• EU GMP Annex 15, Qualification and Validation
• EU GMP Annex 1 (2022), Manufacture of Sterile Medicinal Products
• PIC/S PE 010, Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
• ICH Q9(R1), Quality Risk Management
• ISPE Containment Handbook
• WHO Technical Report Series No. 961 (2011)
• USP 32
• FD X15-140

Validation can be combined with delivery and installation and a preventive maintenance contract, so your equipment stays compliant over its whole lifetime.

Refrigeration Certified

tcps nv is originally a refrigeration-certified company. We not only sell, supply, and install high-quality products, but thanks to our highly trained technicians, we can also carry out repairs and maintenance on all your refrigeration installations and other various equipment.