According to Good Manufacturing Practice (GMP), manufacturers must prove that critical operations are under control by identifying the necessary validation work. Classcon supplies FAT (Factory Acceptance Test) protocol validation for any system. We perform SAT (Site Acceptance Test) and supply any required IQ, OQ and PQ protocols (Installation Qualification, Operational Qualification and Performance Qualification).

Our validation protocols comply to the following standards:

  • ISO 14644 (Cleanrooms and associated controlled Environments)

  • ISO 10648 (Containment enclosures)

  • EEC-GMP (Good Manufacturing Practice – Annex 1 Manufacture of sterile Medicinal Products)

  • PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)

FAT

Factory Acceptance Tests: tests carried out in the construction plant before delivery to show that the system works properly and can be installed and tested on the final site

SAT

Site Acceptance Tests: tests to show that the system works in its final operating environment and that it interfaces correctly with other systems and peripherals.

DQ

Design Qualification: the documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose

IQ

Installation Qualification: the documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.

OQ

Operational Qualification: the documented verification that a system operates according to specifications approved in the specified operating ranges

PQ

Performance Qualification: the documented verification that the facilities, systems and equipment, as connected together, can perform effectively and  reproducibly, based on the approved process method and product specification.

GMP

Good Manufacturing Practices: these are a set of rules, procedures and guidelines on the basis of which medicines, medical devices, diagnostic products, foods and pharmacologically active substances are produced.

GAMP

Good Automated Manufacturing Practices: they constitute the set of «good practices» defined by the technical committee COP (Community Of Practice) which is headed by the International Society of Pharmaceutical Engineering (ISPE).

URS

User requirements Specification (URS): The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system.

Engineering

Classcon΄s engineering department builds HVAC, piping and electricalsystems for GMP-classified environments, Clean Rooms  and production and processing plants

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Clean Room

Classcon΄s prefabricated department is responsible for clean rooms, from thearchitectural layout to the production and assembly of prefabricated products  (floors, walls and pharmaceutical false ceilings)

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Our Works

Classcon offers an end-to-end turnkey service, acting as single point of contact with thecustomer. We work with you during design and implementation, delivering personalized  solutions to satisfy your needs and achieve the best possible result.

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