CLEANROOM VALIDATION

Cleanroom validation

We offer these services both as part of re-qualification for existing facilities and for newly constructed or refurbished premises, ranging from the preparation of VMPs, URSs, DQ right through to the performance of IQ, OQ and PQ qualifications for systems, equipment and cleanrooms, including computerised systems. We also offer consultancy services in the areas of GMP and QA, external audits and training.

Validation and Qualification Collaboration on the creation of VMPs, risk assessments, risk analyses and URS for new projects        Design Qualification – assessment of projects from a GMP perspective Conducting IQ, OQ and PQ qualifications for: Cleanrooms, isolator workstations, ventilation systems Pure media – PW, WFI, PS, compressed air and other gases Selected process equipment and sterilisation equipment Validation of temperature fields, thermal chambers, storage facilities and transport Validation of computerised and monitoring systems in accordance with GAMP and GMP Collaboration on pre-qualification and process validation (PQ and PV) Regular re-qualification, including servicing and calibration
Authorised measurements The AMT Centre is an authorised testing facility for the following measurement areas: Set B3 — Measurement of fibrous dust and indoor air quality classes in buildings Set B4 — Assessment and measurement of microclimatic parameters in the indoor environment of buildings Set H5 — Determination and measurement of microclimatic parameters in the workplace Used in particular for verifying indoor environmental parameters in operating theatres and their ancillary facilities, tissue banks, pharmacies, etc.
Consultancy services We provide a full range of consultancy services covering all regulated activities for clients in the fields of pharmacy, healthcare, the manufacture of medical devices, electrical engineering, biotechnology and other demanding manufacturing sectors. Expert GMP assessment of existing production premises and equipment Expert assessment of existing production processes and related documentation Training and lecturing activities: - Legislation - GMP training - Validation and qualification training - Specific seminars tailored to client requirements

Certifications

ČSN EN ISO 9001:2016, ČSN EN ISO 14001:2016, ČSN ISO 45001:2018

We hold the certificate "Quality Management System".

As part of our commitment to continuous improvement, we have also obtained certification for “Environmental Management System” and for “Occupational Health and Safety Management System”.

These integrated systems are managed in accordance with the applicable standards:

• ČSN EN ISO 9001:2016 - Quality management system
• ČSN EN ISO 14001:2016 - Environmental management system
• ČSN ISO 45001:2018 (OHS) - Occupational Health and Safety Management System

specifically within the scope of activities specified for each individual certificate.

Certificates available for download in PDF format here.

CERTIFICATE OF AUTHORISATION – ANALYSIS, MEASUREMENT AND TESTING DEPARTMENT (AMT DEPARTMENT)

The Analysis, Measurement and Testing Department (AMT Department) of BLOCK SVP has, as an
authorised laboratory in the field of public health protection, following a
technical and QMS audit, been granted an extension CERTIFICATE OF AUTHORISATION pursuant to Act
No. 258/2000 Coll. (the Public Health Protection Act).

The certificate was issued by the National Institute of Public Health in Prague 10, authorised by the Ministry of Health
to carry out authorisation. The AMT Department is a laboratory qualified to carry out activities within the scope
of the following authorisation sets:

• B3 - Measurement of fibre dust and indoor air quality classes in buildings
• B4 - Assessment and measurement of microclimatic parameters in the indoor environment of buildings
• H5 - Determination and measurement of microclimatic parameters in the workplace

Authorisation Certificate No. A0150100121, valid until 4 February 2026.