CleanroomsUSA

Applications for Cleanrooms Part 2

Compounding Pharmacies

Stipulations for pharmaceutical clean rooms follow similar stringent standards as those set for medical devices since they have the same relationship with the public. The standards for pharmaceutical clean rooms are set by the United States Food and Drug Administration (FDA) that regularly adjusts and edits its standards. Clean rooms for the pharmaceutical industry are designed to control humidity that can impact product integrity, air pressure, microorganisms, and temperature.

Meticulous detail and minute scrutiny are a common aspect of pharmaceutical clean rooms to ensure the safety and effectiveness of its products. The adherence to high quality is necessary to prevent medications from being a danger to the public. As with food, drink, and medical instruments, any thing that comes in contact with the public has to be closely regulated.

The compounding pharmacy business has been growing over the last several years and has had restrictions placed on it due to the chemicals and compounds they produce requiring clean rooms. The unique nature of a compound pharmacy is their ability to mix, produce, and sell drugs specifically designed to meet a customer’s needs. The nature of the materials they use makes it necessary for them to have an enclosed sanitary environment. Their clean rooms need to meet the ISO standards levels 7 or 8.

Ballrooms

The ballroom clean room concept makes it possible to scale up or scale down according to the needs of a process. Multiple processes are completed at the same time. Operations or functions are placed on wheels and wheeled to where they are needed. Additionally, a ballroom does not have to be a single large space but can be adjacent smaller spaces connected with through the wall connectors, a concept that is known as a dance floor.

The use of ballrooms maximizes the use of space while lowering capital expenditure. The focus of ballroom clean rooms is to be flexible to meet the changing requirements of products and customers. All personnel and equipment are located in one space with easy access to all operations. The design of a ballroom clean room makes it possible to have a sealed and enclosed space that is capable of completing a full set of operations without having to shift products to various sealed locations.

This class of clean room is used for full scale production operations for precision products. They are unlike mini environments that are designed for the production of one tool or process. Ballroom clean rooms are large with complete production operations. Their major problem is their ability to produce a completely contained environment that is free of contaminants.

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