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What you should look for when hiring a Cleanroom certification company.

What you should look for when hiring a Cleanroom certification company.

When selecting a cleanroom certification company, a facility manager should consider a range of factors to ensure that the chosen company has the necessary expertise, credentials, and experience to effectively certify the cleanroom according to industry standards and regulations. Here are some key factors to consider:

 1. Accreditation and Certifications

  • Industry Accreditation: Look for companies that are accredited by recognized industry bodies, such as the National Environmental Balancing Bureau (NEBB), the Institute of Environmental Sciences and Technology (IEST), or similar organizations specific to your region or industry.
  • Certifications: Ensure the company's personnel hold relevant certifications, such as Certified Cleanroom Testing and Certification Technician, Certified Biological Safety Cabinet Field Certifier, or other relevant credentials.

2. Experience and Expertise

  • Industry-Specific Experience: The company should have experience in certifying cleanrooms in your specific industry, whether it's pharmaceuticals, biotechnology, electronics, aerospace, or another sector that requires controlled environments.
  • Technical Expertise: The team should possess deep knowledge of cleanroom standards, such as ISO 14644 or Federal Standard 209E (for the U.S.), and be familiar with the specific requirements for particle count, air changes per hour, pressure differentials, and other relevant parameters.

3. Comprehensive Services

  • Range of Services: Look for companies that offer a full range of cleanroom certification services, including testing, validation, and certification of air cleanliness, air flow, pressure differential, temperature and humidity control, and recovery rates. Test and Balance experience can really add value.
  • Customization: The company should be able to tailor their services to meet the unique requirements of your facility, including custom testing protocols and certification schedules.

4. Quality Assurance and Documentation

  • Detailed Reporting: The company should provide comprehensive reports that document all testing procedures, findings, and any recommendations for improvement or corrective actions.
  • Compliance: Ensure that the company's testing methods and documentation meet regulatory compliance requirements for your industry, such as cGMP, FDA, or EMA guidelines.

5. Customer Service and Support

Communication: Good communication is essential. The company should be responsive, willing to explain their processes, and able to provide clear answers to your questions.

After-Sales Support: Look for companies that offer ongoing support, consultation, and advice even after the certification process is complete. This could include periodic re-certification, troubleshooting, and updates on regulatory changes.

6. Reputation and References

Client Testimonials: Seek feedback from other facilities that have used the company's services. Positive testimonials and case studies can provide insight into the company's reliability and performance.

Reputation: Research the company's standing in the industry. A strong reputation, backed by years of successful operations, is a good indicator of reliability and quality service.

 7. Cost and Value

Transparent Pricing: Ensure the company provides clear, upfront pricing without hidden fees. 

Value for Money: While cost is an important consideration, it should be balanced against the value provided. The cheapest option is not always the best, especially when it comes to maintaining the integrity of a cleanroom environment.

By carefully evaluating these factors, a facility manager can select a cleanroom certification company that not only meets the technical and regulatory requirements but also aligns with the facility's specific needs and values.