Cleanroom Validation

Principles of Cleanroom Validation

The pharmaceutical industry is subject to heavy government regulation, and pharmaceutical cleanrooms must meet stringent standards and requirements. Cleanroom validation is performed to ensure that the:

design of the facility is fit for its intended purpose
facility, equipment, and environment meet defined regulatory requirements
facility, equipment, and environment meet User Requirement Specifications (URS)
facility, equipment, and its environment function together as a system to meet defined standards.

Our cleanroom validation process include the following six phases:

1

Design Qualification

2

Installation Qualification

3

Operation Qualification

4

Performance Qualification

5

Cleanroom Certification

6

Monitor and Control

Cleanroom Validation Classification

Cleanroom classification – ISO Class

Cleanrooms are classified according to the cleanliness level of the air inside them. The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air. The primary authority in South Africa is the ISO classification system ISO 14644. CRT ensures that your facility cleanrooms are validated and then certified to a chosen class of ISO 14644, which is the primary authority in South Africa. Each class of ISO14544 has its own unique specified classification requirements with the most common class used being ISO 7.

Cleanroom classification – Grade A, B, C or D

Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry.  Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations.  These Grades can be related to the ISO classes.

Cleanroom classification – Class 10 000

The old Federal Standard 209 (class 100 000; 10 000; 1 000; 100; 10; 1) was withdrawn in 2001 and officially replaced by ISO-14644-1 in 1999, but it is still widely used. ISO 7 is equal to Class 10 000 in this context.
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