Cleanroom Validation & Certification Services

Effective cleanroom validation and certification services go beyond just counting pathogen particles, ensuring product and worker safety and product efficacy.

Infinity is ISO 9001 certified and designs and executes cleanroom and autoclave validation and certification programs to adhere to all applicable regulations and standards to minimize compliance, contamination, product loss, and downtime risks.

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:

  • ISO 14698 – Biocontamination control 
  • ISO 14644-1 – Cleanrooms and associated controlled environments
    • Part 1: Classification of air cleanliness by particle concentration
    • Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
  • USP <797> – Personnel, engineering/facility design, and environmental controls for sterile compounding
  • USP <800> – Pharmaceutical compounding  – hazardous drugs
  • cGMP cleanroom requirements

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.

Per ISO14644-3 methods for cleanroom certification, Infinity conducts the  following ten tests:


  • Airborne particle count test
  • Airflow test
  • Air pressure differential test
  • Filter leakage test
  • Flow visualization test
  • Airflow direction test
  • Temperature test
  • Humidity test
  • Recovery test
  • Containment leak test

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.

Environmental Monitoring

Cleanroom validations and certifications provide moment-in-time assessments, whereas environmental monitoring offers ongoing insights. Environmental monitoring usually occurs daily for critical zones and weekly for less critical areas. Infinity Laboratories collaborates with pharmaceutical, medical device manufacturers, and compounders to design and execute environmental monitoring programs per FDA, USP, ISO 13485, and ISO 14698 standards.

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.