* HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.

Validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:

A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.

Methods for evaluation and measurements for Certification are specified in ISO : 14644-3. It calls out for the following ten tests.

Air flow Test & ACPH Calculations

Installed Filter System Leakage Test (using PAO)

Non-Viable Particle Count Test

Recovery Test

Air Flow Pattern Test (Using Water Fogger)

Air Pressure Balancing

Containment test

Temperature & RH Measurement

Light Intensity Measurement

Sound Level Measurement

High Pressure Diffuser

FOG Generator

Handy Camera

Particle Counter

Aerosol Photometer

Aerosol Generator

Air Capture Hood

Vane Type Anemometer

Laminar Air Flow Unit (LAF)

Reverse Laminar Air Flow Unit (RLAF)

Dispensing/Sampling Booth

Bio Safety Cabinet

Garment Cubicle

Sterilizing Tunnel

Dry Heat Sterilizer (DHS)

Animal Changing Station

Individual Ventilation Cage (IVC Unit)

Fluid Bed drier (FBD)

Autocoater – Tablet Coating machine

ULPA Filter Integrity test

 Air Velocity Test

 Filter Leak Test

 Air Flow Pattern Test

 Non viable Particle Count

 Viable Particle Count

 Recovery Test

 Differential Pressure Monitoring

 Temperature & Relative Humidity Monitoring

 Noise & Light Level Measurement

Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.

In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results

Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.

It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

Clean Room and HVAC/AHU Validation/Qualification

Compressed Air/Nitrogen Gas Testing or Validation

Pure steam Quality test

Documentation services

Equipment validation

Facilities validation

HVAC system validation

Cleaning validation

Process Validation

Analytical method validation

Computer system validation

Packaging validation

Cold chain validation

Compressed Air Validation

HVAC Validation

Clean Room Validation

Cold chain Validation

PLC Validation

Thermal Validation

Steam Quality Test

Design validation services

Pharma Validation Services

Data-verification validation services

Clean Room AHU Area Validation Services

Calibration validation

Equipment Validation Services

Flow Calibration

IAQ - Indoor Air Quality

Isolator Validation

Biosafety, LAF Validation

The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:

Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.

Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.

Demonstrates that all facets of the process or equipment are operating correctly.

Demonstrates that the process or equipment performs as intended in a consistent manner over time.

This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

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