A cleanroom is a specially designed room with controlled environmental conditions, where the concentration of airborne particles is kept within specified limits. Cleanrooms are used extensively in sectors like semiconductor manufacturing, life sciences, aerospace, and healthcare where contamination control is critical.
Cleanroom certification involves having an independent third-party testing and certification organization assess the cleanroom to verify it meets the required cleanliness classification standards. The most common standards used are ISO 14644-1 for particulate cleanliness and ISO 14698 for microbial cleanliness. Certification provides validation that the cleanroom’s design, construction, and operational controls can continuously achieve the required cleanliness levels.
Getting a cleanroom certified is important for several reasons. It provides assurance to customers that products are being manufactured in a contaminant-controlled environment. Certification also helps ensure compliance with regulatory requirements in regulated industries. Additionally, it serves as risk mitigation against product defects or batch failures caused by contamination. Maintaining certification requires ongoing monitoring and control, which motivates discipline in contamination control.
ISO Certification
ISO 14644 is a series of standards set by the International Organization for Standardization (ISO) that specifies requirements for the operation and classification of cleanrooms. ISO 14644 helps ensure cleanrooms meet expected particle count and air cleanliness levels.
The main ISO 14644 standards related to cleanroom certification are:
- ISO 14644-1: Classification of air cleanliness
- ISO 14644-2: Specifications for monitoring to prove continued compliance
- ISO 14644-3: Test methods
- ISO 14644-4: Design, construction and start-up
- ISO 14644-5: Operations
ISO 14644-1 classifies cleanrooms into 9 different ISO classes based on the maximum concentration of airborne particles per cubic meter. For example, an ISO Class 5 cleanroom has a maximum of 352,000 particles of 0.5 microns or larger per cubic meter of air, while an ISO Class 8 cleanroom can have up to 3,520,000 particles per cubic meter.
To get ISO 14644 certification, cleanrooms undergo testing by an accredited certifying body. Testing confirms the cleanroom meets the ISO particle count standard for its target ISO class. Recertification audits are required at least annually to maintain ISO certification.
EU GMP Certification
The EU GMP (Good Manufacturing Practice) guidelines provide standards for the manufacture of medicinal products for human and veterinary use in the European Union. The EU GMP requirements for cleanrooms are outlined in Annex 1 of the guidelines.
The EU GMP standards require that cleanrooms be designed to minimize contamination and allow for effective cleaning. Cleanrooms must meet specified environmental standards for particulate and microbial contamination based on an established classification system. There are general GMP requirements as well as more specific standards for cleanroom equipment, ventilation, water systems, and more.
To achieve EU GMP certification for a pharmaceutical cleanroom, manufacturers must go through an application and inspection process. The steps generally include:
– Preparing documentation describing the facility design, equipment, systems, cleaning procedures, monitoring program, and other GMP elements.
– Submitting an application to the national regulatory authority of an EU member state.
– Undergoing an on-site inspection by the regulatory authority’s qualified inspectors.
– Addressing any deficiencies found during the inspection.
– Receiving an EU GMP certificate if the facility is determined to be compliant.
Maintaining certification requires ongoing compliance with EU GMP standards as well as periodic re-inspections, typically every 1-3 years. Any significant changes to the certified cleanroom require approval from the regulatory authority.
Overall, EU GMP certification provides confirmation that a pharmaceutical cleanroom meets the necessary quality standards for protecting drug product quality in the European market.
Choosing a Certifying Body
When seeking cleanroom certification, the first major decision is choosing the certifying body that will conduct the audit. There are a few main options to consider:
Third-party certification bodies: These independent companies specialize in cleanroom certification and auditing, such as Gerbig Cleanrooms or American Cleanrooms. They often have the most expertise. However, using a third-party can be more expensive.
Internal auditors: Some companies use internal quality assurance or compliance staff to self-certify their cleanrooms. This is less expensive but can be seen as less credible than third-party certification.
The main tradeoff is between credibility and cost. Independent third-party certifiers often provide the most rigorous and trustworthy validation. But using internal auditors saves money, especially for companies certifying multiple cleanrooms. Organizations should weigh the pros and cons when deciding what fits best for their specific needs and budget.
Preparing for Certification
To successfully pass the certification audit, an extensive amount of preparation, planning, and practice should be conducted beforehand. Cleanroom facilities must understand the certification standards and requirements they will be audited against, and take the following steps for getting the cleanroom ready:
First, develop a detailed checklist covering all aspects of the certification standards. For ISO certification, this means going through ISO 14644-1 and 14644-2 line-by-line to identify requirements. Review blueprints, protocols, SOPs, logbooks, and documentation to ensure all specifications and procedures meet standards. Assemble documentation neatly with highlighted important details to have ready for auditors [1].
Conduct internal audits using the checklist to identify any gaps or issues that need remediation. Ensure all equipment is calibrated and validated, gowning and personnel protocols are strictly followed, pressure differentials are properly maintained, and cleaning and sanitization procedures are effective. Address any non-conformities discovered to get the cleanroom fully prepared.
Proper documentation and record-keeping is crucial for traceability and providing evidence to auditors. Cleanroom SOPs, floor plans, logs, monitoring records, maintenance schedules, and personnel training must be complete, consistent, and accessible. Auditors will check that protocols match actual observed practices [2].
Following these steps will ensure your cleanroom facility is truly ready for a successful certification audit.
The Certification Audit
The onsite certification audit is a thorough inspection of your cleanroom facility to ensure it meets the requirements of ISO or EU GMP standards. Here’s what to expect during the audit:
The auditors will visually inspect all areas of the cleanroom, including the gowning rooms, airlocks, cleaning and sanitization areas, and the production floor. They will check that proper gowning procedures are followed, air filtration systems are functioning correctly, and that cleaning and maintenance protocols are being implemented according to standard operating procedures (SOPs).
Production equipment, utilities like pure water systems, environmental monitoring data, and documentation like SOPs and training records will be reviewed. Auditors will verify that all processes are performed according to approved procedures and that any deviations are documented and addressed. They will check that equipment is properly calibrated and maintained [1].
Cleanroom staff at all levels will be interviewed to evaluate their training and knowledge of cleanroom protocols. This ensures they understand and follow all SOPs. Staff will be asked about their specific duties, procedures they follow, how they handle exceptional events, etc. [2]
Any deficiencies found during the audit will need to be addressed before certification can be awarded. The auditors will provide a detailed report with their findings and recommended corrective actions.
Maintaining Certification
To keep your cleanroom certification valid, there are certain requirements you must meet on an ongoing basis. These include:
Conducting periodic re-audits
Most certification bodies will require you to undergo regular surveillance audits after initial certification to ensure your cleanroom remains compliant with standards. The frequency varies, but annual audits are typical for ISO certifications (1).
Notifying auditors of any significant changes
You must inform your certification body if you make any major changes to your cleanroom that could impact compliance, such as changing the cleanroom layout, replacing the HVAC system, or switching disinfectants. Minor routine maintenance and repairs may not need to be reported, but confirm requirements with your specific certifier (1).
Staying organized with logs for maintenance, environmental monitoring, training records, and more will help ensure you meet recertification criteria and pass your surveillance audits (2). Regular cleanroom maintenance and testing is key for maintaining certification validity (3).
Sources:
(1) https://www.sepsservices.com/resources/the-basics-of-cleanroom-testing-certification/
(2) https://www.golighthouse.com/en/blog/cleanroom-maintenance-checklist-607/
(3) https://www.colandis.com/en/cleanroom-maintenance
Recertifying a Cleanroom
A cleanroom’s certification is typically valid for a set period of time, which varies depending on industry and regulatory requirements. For example, ISO 14644 requires recertification every 12 months, while EU GMP guidelines mandate certain cleanroom certifications to be renewed every 6 months.
The process for recertifying a cleanroom is similar to the initial certification. It involves working with an accredited third-party certification body to schedule and conduct tests that confirm the cleanroom still meets the required ISO classification or GMP grade. This includes particle counting and microbiological testing.
The certification body will provide thorough reports indicating pass or fail results for each cleanroom classification parameter. Failed tests require taking corrective actions to address issues before the room can be recertified. Once the cleanroom passes all recertification testing and documentation requirements, an updated certificate is issued.
Recertification is critical for regulated industries to demonstrate ongoing compliance with standards. It also verifies that proper conditions are maintained over time through monitoring, preventive maintenance and effective cleaning procedures.
Certification Costs
The cost of initial cleanroom certification can vary greatly depending on the size and classification level of the cleanroom. Some key factors that impact certification costs include:
- Size of the cleanroom facility – Larger facilities will require more time for audits and testing.
- Number of cleanroom classifications – Facilities with multiple ISO classifications will require additional testing for each class.
- Choice of certifying body – More renowned certifying organizations typically charge higher fees.
- Geographic location – Certification costs are usually higher in areas with higher labor costs.
According to the Cost of a Modular Cleanroom per Square Foot, initial certification costs can range from $5,000 for a small cleanroom up to $100,000+ for a large multi-class facility. Ongoing costs for maintaining certification through annual audits and renewals every 3 years are typically 20-30% of the initial certification investment.
When budgeting for cleanroom certification, it’s important to get quotes from several reputable certifying bodies to compare costs. Be sure to factor in both initial and ongoing expenses over the expected life of the cleanroom.
Conclusion
Certifying a cleanroom is an investment that can pay valuable dividends. While the process requires time, preparation and costs, the benefits are numerous. Certification validates that your facility meets rigorous quality standards and hygiene requirements. This provides assurance to clients and regulators that your cleanroom environment is controlled and contamination risks are minimized. Certification also communicates credibility and trustworthiness. Companies with certified cleanrooms are recognized for their commitment to quality. Certification can open new business opportunities and give you a competitive edge. It also reduces compliance risk and the chances of costly errors or failures. The certification process prompts facilities to thoroughly evaluate operations, identify areas for improvement and implement best practices. This ultimately yields a more efficient, optimized cleanroom. In summary, certification takes dedication but helps secure your reputation, gain client confidence, access new markets and operate at peak performance. The investment strengthens quality systems and pays dividends through reduced risks, operational improvements and business growth.