Validation & Qualification of Clean Rooms

VALIDATION, QUALIFICATION, AUTHORIZED MEASUREMENTS, MEASUREMENT REVIEW

BLOCK^® AMT (Analysis, Measurement and Testing) Department offers comprehensive validation and qualification services through a team of experienced validation engineers and specialists with advanced equipment. We offer these services for both re-qualification for existing facilities and for newly constructed or refurbished facilities, ranging from the preparation of VMP, URS, DQ to the execution of IQ, OQ and PQ qualifications for systems, equipment and cleanrooms, including computer systems. We also offer GMP and QA consulting, external audits and training.

VALIDATION AND QUALIFICATION

Collaboration in the development of VMPs, risk assessments, risk analyses and URS for new projects
Design Qualification - assessment of projects from a GMP perspective
Performing IQ, OQ, PQ qualifications for:

Cleanrooms, Isolator Workstations, HVAC Systems
Pure media - PW, WFI, PS, compressed air and other gases
Selected technological and sterilisation equipment
Validation of temperature fields, thermal chambers, warehouses, transport

Validation of computer and monitoring systems according to GAMP and GMP
Cooperation in process qualification and process validation (PQ and PV)
Regular retraining including service and regulation

AUTHORISED MEASUREMENTS

The AMT Department of the BLOCK^® Holding is an authorized laboratory in the areas of:

Set B3 - Measurement of fibrous dust and indoor environmental cleanliness classes
Set B4 - Detection and measurement of microclimatic parameters in the indoor environment of constructions
Set H5 - Detection and measurement of microclimatic parameters in the working environment

Particularly useful in the verification of parameters of the internal environment of operating theatres and their facilities, tissue banks, pharmacies, etc.

CONSULTING SERVICES

We carry out consulting services in the full range of performed and regulated activities for customers in the fields of pharmaceutics, healthcare, medical device manufacturing, electrical engineering, biotechnology and other high end production.

EXPERT ASSESSMENTS AND GMP AUDITS

Expert GMP assessment of existing production facilities and equipment
Expert assessment of the existing production process and related documentation

TRAINING AND LECTURING ACTIVITIES

Legislation
GMP training
Validation and Qualification training
Specific seminars based on customer requirements