Cleanroom Validation & Certification Services
ServicesCleanroom Validation & Certification ServicesEffective 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.
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
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.
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 and medical device manufacturers to design and execute environmental monitoring programs per FDA, USP, ISO 13485, and ISO 14698 standards.