Validation & Qualification Services

 Our highly qualified and experienced cGMP compliance and validation team provides a comprehensive range of validation services:

• Systems impact assessment

• Validation Master Planning,

• Design qualification

• Preparing and executing of  Installation/ Operation/ Performance Qualification (IQ, OQ, and PQ) protocols

• Full validation project management.

   Special Services and Testing

In accordance with Good Engineering Practices (GEP) and corporate quality standards, GBH Group provides a wide range of qualification services for the High Technology industries and laboratories facilities.

Developing and implementing systems-impact assessment and provide a full qualification and testing program to total-controlled facilities. This includes facility, equipment, utilities, and heating, ventilating, and air conditioning (HVAC) systems testing and qualification.

a.      HVAC Qualification and Testing

GBH Group provides what is called TAB process (Testing, Adjusting, and Balancing) which is used to achieve proper operation of heating, ventilating, and air conditioning systems, also called environmental systems.

Special calibrated instruments are used to measure temperatures, pressures, rotational speeds, electrical characteristics, velocity and air and water qualities for an evaluation of equipment and system performance.

DOP tests using aerosol generators and photometers to integrity test or locate leaks in high efficiency air filters (HEPA/ULPA filters).

Our service helps customers to quickly and quantifiably pinpointing filter deficiencies such as pinholes, thin spots, and gasket leakage

b.      Thermal Validation(Heat Distribution/Penetration Studies)

GBH Group provides world class thermal validation services to pharmaceutical, biotech, food, and high-tech industries.

 GBH Group’s thermal validation specialists are capable of using either the industry standard Kaye Instruments thermal validation technology or LIVES International thermal process validation system.  .
The GBH Group’s staff has performed sterility testing for autoclaves, lyophilizers, and sterilize-in-place cycles for various systems

GBH Group also provided thermal mapping services for stability chambers, ovens, cold-Rooms, vacuum ovens and freezers from small laboratory units to larger walk-in units