ISO and GMP Cleanroom Standards

 

Cleanrooms are used to control the concentration of airborne particles during contamination-sensitive activities in industries such as pharmaceuticals, biotechnology, medical devices, healthcare and food. Air cleanliness in cleanrooms is classified according to the International Organization for Standardization (ISO), a worldwide federation comprised of national standards bodies, based on cumulative distributions of particle populations that range in sizes from ≥ 0.1 µm to 5 µm.

 

 

According to both USA and EU Good Manufacturing Practice (GMPs), cleanroom classifications should be carried out according to ISO 14644-1. This ISO classification impacts every cleanroom user in the GMP community. GMP compliance can be achieved when consistent GMP-grade materials from well-characterized sources are implemented and utilized.

 

While maintaining laboratory quality standards has always been critical, the increased focus on strictly controlled environments will continue to expand with stem cell research and regenerative medicine demands. Therefore, as cleanroom certification for GMP manufacturing grows in importance, it is vital to select core laboratory equipment that meets ISO certifications and facilitates cleanroom status.

 

 

One of the most impactful precautions laboratories and clinical manufacturers can take in avoiding contamination is establishing and maintaining a cleanroom that meets Good Manufacturing Practice (GMP) guidelines. Learn more about cleanrooms, GMPs and ISO Certification in this free application note. Download Application Note

PHCNA understands that ISO cleanroom classified equipment is essential in achieving high quality, repeatable results that meet cleanroom and GMP Guidelines. Our ISO certification provides the reassurance you need that your facility can meet the demands of cleanroom and GMP guidelines without compromising equipment performance. PHCbi brand products have been carefully designed, engineered and constructed to fit seamlessly into any space or protocol.

 

Our flagship ultra-low temperature freezer and cell culture incubators are classified in accordance with part 14 of ISO 14644. These products are ISO-classified by an Occupational Safety and Health Administration (OSHA) approved testing laboratory.¹

 

MCO incubators have minimal moving parts and optimize decontamination protocols while minimizing contamination risks.

 

Cell-IQ™ Series MCO Incubators (MCO-170AICUVHL-PA and MCO-230AICUVL-PA) are ISO Class 5.0 classified and use the PHCbi brand Direct Heat and Air Jacket system for precise temperature control. The MCO-80ICL-PA is ISO Class 5.5 classified and provides a large capacity with minimal CO₂ consumption. In addition, the full line of PHCbi brand MCO incubators feature seamless inCu-saFe® interiors, a copper enriched stainless-steel material for additional germicidal protection.

 

 

 

 

The MDF-DU702VXC-PA TwinGuard® Series ultra-low temperature freezer is built with a unique sealed refrigeration system, coupled with a sealed bearing design on the cooling fans to reduce particle emissions.

 

The upright -80°C freezer is ISO Class 6.0 classified and ideal for the long-term storage of vaccines, cell cultures and tissues, rare specimens, biological materials and other high valued products.

 

 

 

 

¹For the full list of OSHA approved testing laboratories that are recognized as meeting the standards and requirements necessary to test and certify products for cleanroom standards, visit osha.gov/nationally-recognized-testing-laboratory-program/current-list-of-nrtls.

 

 

 

About PHC Corporation of North America

PHC Corporation of North America, located in Wood Dale, IL, is a leader in laboratory equipment for the biopharmaceutical, life sciences, academic, healthcare and government markets. Product lines under the PHCbi brand include the space saving and energy efficient VIP® ECO and TwinGuard® ultra-low temperature freezers, cryogenic and biomedical freezers, pharmacy and high-performance refrigerators, cell culture CO₂ and multigas incubators, and Drosophila/plant growth chambers. PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, which is a global healthcare company that develops, manufactures, sells, and services solutions across diabetes management, healthcare solutions, diagnostics and life sciences.