Validation and Qualification

Validation and Qualification

BLOCK® performs validations and qualifications on all process levels of diverse equipment and systems.

 

Process Levels

  • Co-operation when setting up VMP

  • Design Qualification (DQ) / Project Qualification (PQ) / Exchange Design Review (EDR)

  • Factory Acceptance Test (FAT) / Site Acceptance Test (SAT)

  • Installation Qualification (IQ)

  • Operation Qualification (OQ)

  • Performance Qualification (PQ)

  • Process Validation

  • Validation of computerized systems

  • Validation thermal fields / Transport

 

Equipment and Systems

  • Cleanrooms
    Heating, ventilation, air conditioning, and cooling equipment (HVAC&R), locations with laminar flows, boxes, laminar flow boxes, microbiological boxes, biological safety cabinets, biohazard equipment, barrier-type working sites, isolators, isolator working sites, boxes for stability testing, storage rooms – monitoring, temperature maps.

  • Clean media
    Water for injections systems (WFI), purified water systems (PW), clean steam systems, systems of compressed air, nitrogen and other gases.

  • Technology
    Steam sterilizers (autoclaves), hot air sterilizers, reactors, washers and driers, thermostats, CIP/SIP systems, production equipment.

  • Control and monitoring systems
    HVAC&R systems, media systems, production, process and technological sets.

 

In the fields of 

  • Pharmaceuticals
  • Healthcare
    • Operation theaters
    • Hospital pharmacies
    • CAR
  • Electro-technical Industry
  • Automotive Industry
  • Foodstuffs Industry
  • Nanotechnology Industry
  • Biotechnology Industry

 

Authorised Measurements

With a special and QMS audit and being an authorized laboratory in the field of public health, BLOCK's Department of Analyses, Measurements and Testing (AMT) has obtained an extended CERTIFICATE IN AUTHORIZATION in compliance with Statute No. 258/2000 Coll. (Statute on protection of public health). BLOCK has maintained this certificate since 2009.

The certificate was issued by the National Institute of Public Health in Prague entrusted by the Ministry of Health to perform authorizations. The AMT Department is a laboratory qualified to perform activities to the extent specified in the authorization sets below:

  • B3 - Measurement of filamentous dust and purity classes of indoor environment of structures
  • B4 - Investigation and measurement of microclimatic parameters in indoor environment of structures
  • H5 - Investigation and measurement of microclimatic parameters in working environments

Our Certificate in Authorization number is A0070100116 and is valid through 4 February 2021.