Cleanroom Validation

Lab prova | Cleanroom Validation

Validation is an essential part of Good Manufacturing Practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.

Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be beneficial for protection of product or process integrity in applications in industries such as pharmaceuticals, medical devices, healthcare, food, aerospace and microelectronics.

Following the EU GMP, U.S. FDA, ISO/TC, PIC/S Guides, WHO | TRS or other regulatory requirements, validate with us your clean room process!

We are ready to help you in force to create appropriate approach, completing each step in this process to reach the goal – to establish the confidence that the manufactured products will consistently meet their product specifications.

Our specialized team of experts is ready to assist you on the road to GMP compliance.

Lab prova | Cleanroom Validation

OUR SERVICES

Validation is an essential part of Good Manufacturing Practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process.

HVAC Commissioning and Qualification

A well designed Heating, Ventilation and Air-Conditioning (HVAC) system play an important role in ensuring the manufacture of quality pharmaceutical and microelectronic products.

Equipment Qualification

All equipment involved in critical activities, such as air handling and filtration equipment, sterilization equipment, process equipment, laboratory equipment, thermal equipment, etc. should be subject to qualification.

Compressed Air Qualification

Compressed air in most of the GMP production processes comes into direct contact with the product, and as such needs to be identified as critical utility the variability of which has an impact on the product quality and therefore should be monitored or controlled.

Thermal Mapping

Facilities, equipment, systems, vehicles and containers used to distribute, store or handle products that requires controlled temperature conditions within specified range, need to be appropriately verified in terms of their designed purpose.

Validation and Qualification Documentation

All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, systems, process and product into consideration.

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