The Importance of Cleanroom Certification

Having up-to-date clean-room certifications is crucial to your business, to your brand, and to your customers. It can be a hard plan to stick to and one we’ve had to help some of our clients with. A cleanroom, particularly in the health industry - hospitals, clinics, health institutions, experimental sites, and pharmaceuticals - are highly-regulated environments that need to follow strict protocols and guidelines due to the sensitive nature of the materials handled and procedures taking place in them. These types of environments are not only expensive to build but their continued maintenance/certification is demanding as well. 

How does cleanroom validation & certification work?

Engineers in certification tailor their specifications to your cleanroom’s requirements and what your main goal is in having one. Each cleanroom is different and the specs it needs to satisfy contrast from others of its kind. 

Generally, a validation process takes into account the following:

• Airborne particle concentration.

• HEPA Filter leak testing. 

• Airflow volume and velocity testing.

• Room Air Change Rates.

• Pressure differences

• Cleanliness Recovery Time/Rate. 

In the medical manufacturing field, cleanrooms play a critical role in ensuring product safety to hasten a patient's successful recovery. Hospitals, pharmacies, pharmaceutical plants, treatment facilities, and others of its kind need to minimize airborne particulates and maintain a robust antimicrobial ambiance. Certifications and validations assure that the healthcare facility has the most efficiently controlled environment and is doing everything within its power to fight the rising rate of hospital-acquired infections and protect its initial investment. 

Cleanroom Classifications/Certificate

MTI, Inc will make sure that your cleanroom has been certified properly and is firmly sticking to the cleanliness levels for which it was built. Our testing takes into account the quantity and size of particles per cubic meters of air in a controlled environment among several other tests. The primary authority for room cleanliness is ISO-14644. ISO classification and certification starts at ISO 1 (the most hygienic) to ISO 9 (The dirtiest — which is nonetheless cleaner than a regular room). MTI will also provide a Compliance Certificate

Cleanroom Certification - Why It Matters

In addition to financing the necessary equipment & filtration when building a cleanroom, the environment itself has to comply with specific regulations to operate efficiently in cost, safety standards, and processes. Cleanroom validation involves conducting a variety of tests to verify the standards and guidelines are being met. 

Certification is one of the most important validations your healthcare or pharmaceutical institution will need as it protects the overall safeguard of your investment & can also identify sources of contamination. It also ensures that your cleanroom complies with its design ISO Classification and the core concept behind its existence. That is in fact a, well, clean room. 

Failure to maintain current certification after the initial validation process puts your business/revenue at risk with higher repair & maintenance costs. Oftentimes these are a direct derivative of issues that could have been repaired at a fraction of cost if detected & addressed earlier, but it opens it up to Federal & State scrutiny. This will end up disrupting your operations and profitability. 

MTI, Mechanical Testing, Inc, is an AABC Cleanroom Performance Testing firm as well as a member of CETA (Controlled Environment Testing Association). We will make sure the certification process is seamless and can identify any deficiencies to communicate them to you in a timely manner. As part of identifying deficiencies MTI will also propose repair solutions to get your facilities back to proper working order.