What is Cleanroom Certification?
Cleanroom certification is the process of evaluating, testing, and verifying that a controlled environment meets specified cleanliness, safety, and regulatory standards. This ensures that airborne particles, airflow, pressure differentials, temperature, humidity, and other critical parameters align with industry guidelines such as ISO 14644, EU Annex 1, and USP 797.
Why is Cleanroom Certification Important?
- Regulatory Compliance: Ensures adherence to FDA, GMP, ISO 14644, and USP 797 standards.
- Product Integrity: Reduces contamination risk and supports high-quality manufacturing.
- Operational Efficiency: Improves equipment performance and extends cleanroom lifespan.
- Risk Mitigation: Prevents costly product recalls and process deviations.
- Audit Readiness: Demonstrates commitment to quality and compliance.
Cleanroom Certification Procedure
Quantus follows a structured certification procedure, based on industry standards, which includes:
1. Pre-Inspection & Setup
- Establish occupancy state (As-Built, At-Rest, Operational).
- Disable smoke detectors if HEPA leak testing is required.
- Ensure proper cleanroom operational conditions.
2. Primary Certification Tests
- Airflow Testing: Measures airflow velocity (unidirectional) or volume (non-unidirectional).
- Air Changes Per Hour (ACPH): Determines cleanroom air exchange rate.
- Room Pressurization: Checks pressure differentials to prevent cross-contamination.
- HEPA Filter Leak Test: Ensures filters meet required efficiency standards.
- Particle Count Survey: Validates airborne particle levels align with cleanroom classification.
3. Optional Secondary Tests
- Temperature & Humidity Monitoring
- Lighting & Noise Level Testing
- Containment Leakage Test
- Room Recovery Rate Assessment
4. Post-Testing Activities
- If parameters are out of tolerance, notify the client before making any adjustments.
- Update certification labels and generate final certification reports.
Partner with Quantus for your cleanroom certification needs. Our experts ensure compliance, operational efficiency, and risk mitigation for your controlled environments. Contact us today to schedule your cleanroom certification assessment.
Quantus specializes in the certification of a diverse array of cleanrooms, including modular, soft wall, and permanently constructed facilities. Our certification process adheres to rigorous standards outlined in our Cleanroom Certification Procedure, ensuring your cleanroom meets precise criteria for air cleanliness, pressure, lighting, and more. Whether you operate a Unidirectional or Non-Unidirectional Cleanroom, our approach includes mandatory tests such as Airflow Volume and Velocity, HEPA/ULPA Filter Leak Tests, and Particle Count Surveys. Additionally, we can conduct optional evaluations like Room Recovery and Airflow Parallelism Tests upon request. We follow a detailed procedure to guarantee that your cleanroom's performance aligns with essential industry standards, including ISO 14644, EU Annex 1, and USP 797, providing confidence in your operational integrity and compliance.
At Quantus Inc., our unwavering dedication to excellence ensures that we not only meet industry benchmarks but continuously aim to exceed them. We understand that reliability and timeliness are crucial to your operations. That's why we stand by our schedules, ensuring punctuality and efficiency in every project. For equipment certifications, we provide same-day reporting to maintain transparency and swift communication. For larger-scale cleanroom validations, comprehensive reports are delivered within two weeks. Moreover, we diligently track the condition of HEPA filters, providing proactive alerts and assistance in their ordering and replacement as needed. Our commitment to your success is reflected in every aspect of our service, from our precise scheduling to the detailed aftercare we provide.
Our team of experts is extensively trained and stays abreast of the latest developments in cleanroom standards. We conduct thorough assessments and certifications using the most advanced techniques and equipment. Our processes are designed to adhere strictly to international standards such as ISO 14644, EU Annex 1, and USP 797, providing you with a certificate of compliance upon successful completion.
Absolutely. Whether you require routine certification for a single cleanroom or coordination of extensive cleanroom systems for new manufacturing facilities, our experienced team is equipped to manage projects of any scale with precision and efficiency.
The frequency of cleanroom certifications can vary depending on industry requirements, the specific class of the cleanroom, and the type of activities conducted within. Generally, certifications are recommended every 6 to 12 months, but we at Quantus provide customized support based on your operational needs and will help you establish a routine certification schedule based on risk factors that may impact personnel safety or product quality. Ongoing support and consultation services are also available to ensure continuous compliance and performance.
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