Independent Test Laboratory (Accreditation certificate No. РОСС RU.0001.21.ЭК 93 by the Federal Agency on Technical Regulating and Metrology) provides complete certification (validation, qualification) cycle in full compliance with GMP and LMP requirements as well as the RF standards (Industry-Specific Standard (OST) 42-510-98 and State Standard (GOST) Р 52249-2004).
Qualification of the equipment assembly and installation location (Installation Qualification – IQ);
Qualification of key systems operation (Operation Qualification – OQ);
Qualification of operating performance (Performance Qualification – PQ).
The Laboratory has modern high-precision metering equipment and skilled specialists.
CERTIFICATION of EU Imtex test laboratory embraces:
• Laminar flow boxes
• Clean rooms and clean areas
• Steam sterilizers (autoclaves)
• Hot-air sterilizers (hot-air cabinets)
• Hot-air and water-jacketed temperature-controlled cabinets
• Incubators
• Refrigerators and deep-freezers
• Climatic chambers
• Freeze drying systems
• Physical measurement of occupational environment / workplaces
The reports and qualification protocols executed on the basis of testing data and submitted to Customer are included in reporting instruments related to the production validation and can be used for developing corrective activities or supporting an arbitration case if the delivered/purchased equipment properties fail to comply with Manufacturer’s specification.
Independent Test Laboratory (Accreditation certificate No. РОСС RU.0001.21.ЭК 93 by the Federal Agency on Technical Regulating and Metrology) provides complete certification (validation, qualification) cycle in full compliance with GMP and LMP requirements as well as the RF standards (Industry-Specific Standard (OST) 42-510-98 and State Standard (GOST) Р 52249-2004). 
