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This pharmaceutical manufacturing company contacted MECART to provide more than 4,500 square feet of cleanroom spaces divided into three distinctive areas for the company’s compounding facility:
The compounding cleanrooms and the powder containment cleanrooms are all in operation under ISO 6, ISO 7, and ISO 8 classifications, but most cleanroom spaces are within the ISO 7 cleanliness level.
All the cleanrooms that MECART has manufactured have been built to respond to the current good manufacturing practices (cGMP) strict guidelines and USP 797 and USP 800 chapters under the United States Pharmacopeia Regulations.
The HVAC designed by MECART provides clean air for use in MECART cleanrooms and in cleanrooms already installed on-site by competitors.
The HVAC can offer two types of air pressure at the same time. Powder and hazardous sterile compounding cleanrooms require negative air pressure, while non-hazardous sterile compounding cleanrooms require positive air pressure.
Most of the cleanrooms, divided into 17 small rooms, provided by MECART are dedicated to the pharmacy compounding of non-hazardous sterile preparations.
The non-hazardous cleanroom zones are divided into three cleanliness levels: ISO 6, ISO 7, and ISO 8. The non-hazardous sterile compounding cleanrooms have positive pressure, meaning that the HVAC system pumps clean, filtered air into the structure to provide an air-pressure level greater than that of the surrounding environment.
For this cleanroom section, there are only two rooms that are dedicated to ISO 6 activities: the sealing-and-filling room and the GMP fill finish room.
There are two types of compounding cleanrooms: isolation cleanrooms and containment cleanrooms.
The fundamental difference between an isolation cleanroom and a containment cleanroom is the ventilation system and its airflow.
For pharmaceutical manufacturing, isolation cleanrooms refer to a positive-pressure environment suitable for ultra-clean procedures, aseptic workflows, pharmaceutical preparations, and other bio-sensitive applications.
Compounding pharmacists use isolation cleanrooms for non-hazardous sterile preparations, anterooms, and corridors.
The powders used for manufacturing drugs and medicines are stored in the powder containment cleanrooms or active pharmaceutical ingredients (API) cleanrooms.
In simple terms, there are two main reasons why the cleanroom is essential for API and powder storage.
The powders and APIs cleanrooms are designed to ensure excellent storage conditions as they must be kept in a dry, clean place and maintained within acceptable temperature limits.
Powder containment cleanrooms also must be in compliance with specific cleanliness levels. In this case, the powder containment cleanrooms provide an ISO 8 level of cleanliness with Clean Non-Classified (CNC) for the background zones, such as the corridor.
Pharmaceutical organizations and pharmacies must maintain the proper containment of their API powder substances since the substances can be hazardous if swallowed in large quantities or explosive if allowed to go airborne.
Since powders can be explosive, proper preparation and safeguards are imperative. To avoid any chance of sparks or flames, special non-sparking switches (dry contacts) and anti-static devices have been integrated into the cleanroom.
Because of those hazards, those cleanrooms are maintained with negative air pressure.