Cleanroom Validation & Certification Services

Cleanroom Validation

Cleanroom validation is required when a cleanroom is first commissioned or there are changes in its design or intended use. Infinity designs validation programs that comply with all relevant regulatory requirements and standards, including:

Female scientist interfacing with Infinity Cleanroom equipment

Cleanroom Testing & Certification

Cleanroom validation must be performed for new cleanrooms or when a cleanroom has changed design or intended use. However, cleanroom testing and certification are performed regularly per cGMP, ISO, and Institute of Environmental Sciences Technologies (IEST) standards to verify compliance and that all cleanroom systems continue to meet validated criteria.


An operation’s cleanroom testing and certification cadence will vary depending on the class or grade of the cleanroom. Although organizations can certify annually, many pharmaceutical, compounders, and medical device organizations must certify every six months. Cleanroom certification is also conducted if a problem is identified or suspected.

Female scientist working with cleanroom equipment

cGMP Cleanroom Validation

cGMP cleanroom validation provides documented evidence that a cleanroom meets a high level of control appropriate for a Grade A, B, C, or D cleanroom. Infinity’s cleanroom qualification and validation services include:
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Installation Qualification (IQ)

Verifies that a cleanroom is consistent with specified designs after installation.

Operational Qualification (OQ)

Verifies that cleanroom equipment achieves specified operational requirements.

OQ Report

OQ report review and closure.

Performance/Process Qualification (PQ)

Verifies that cleanroom equipment performs well together in a cohesively controlled, repeatable state. One static and three dynamic qualification sessions are typically performed.

PQ Report

Full PQ report and executive summary.

Autoclave Validations

An autoclave must adhere to eEN 285 and ISO 17665 standards to maintain safety and sterility. Autoclaves must be validated when commissioned and periodically certified to ensure the continuation of specified sterility parameters.

In addition to achieving the appropriate temperatures and cycle times,  other critical measurements include:
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Equilibration Time

The equilibration time refers to the duration from when the initial sensor reaches the designated temperature until the final sensor accomplishes the same. This measurement acts as an indicator of your autoclave’s uniformity.

Spread of Temperatures

The temperature variance within an autoclave reveals heat dispersion across the chamber throughout the sterilization process.

Sensor Deviations

Indicates that the temperature sensors remain within their acceptable range.
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Environmental Monitoring

Get in Touch

Want to learn more about our ability to support your cleanroom validation and certification needs in California? Connect with one of our team members today.