Contract Packaging in a Clean Room Environment

In the contract packaging process, some products require additional precautions to insure that they are handled properly and that the package contents are not compromised. Some products need to be packaged in an isolated area within a facility known as a “clean room”. A clean room is a regulated packaging environment that can facilitate packaging of items that are sensitive to contamination. This doesn’t necessarily mean sterilization, but does mean a designated set of protocol must be followed according to specific product needs. Typically these environments must adhere to strict guidelines pertaining to the room itself, and the process in which it is packaged along with the materials that the product is being packaged.

Clean Room Requirements

The requirements for a clean environment can differ based on product type. These requirements depending on the certifying entity and the guidelines set forth by the product retailer. To make sure the guidelines for the clean room are being followed, production plants are routinely subject to audits.

One of the most important requirements for all clean rooms is making sure they have the proper equipment installed. For example a clean room must have a specialized reverse airflow filtration system. This air filtration system is completely separate from that of the rest of the packaging plant and serves to help control the environment by keeping it free of dangerous or unwanted elements in the air. Along with the air filtration, clean rooms have monitored temperature and humidity control in place. By regulating these conditions in the room both temperature sensitive or hydroscopic products can be packaged with a minimal risk of contamination. Clean rooms are also helpful when dealing with products that contain allergens such as peanuts or soy. There are procedures for handling allergens that are carefully monitored and documented.

Clean Room Applications

Products that you would typically see utilizing a clean room for product packaging would be Medical supplies, Pharmaceuticals, OTC products, primary food packaging, hospital wearables such as gowns and masks, Neonatal products and more. It may be good to note that a clean room is rated for medical and pharma applications (Ex: Class 100,000, class 10,000 and class 1,000). This indicated the number of dust particles measured per cubic inch. For primary food filling, however, the production environment is not rated, per se, by dust particles but has other requirements as spelled out by the industry governing parties such as AIB (Association of international Baking), Cookes and Thurber, and SQF, to name a few.

Clean Room Specifications

Along with the room itself, the clean room specialists must adhere to product-specific regulations. This could include but not be limited by: wearing protective garments, wearing sterile gloves and/or wearing eye protection if necessary. The specialists must undergo training to educate them on proper procedures and quality control protocol. They are also trained in sterilized packaging techniques, cleaning requirements, and system-monitoring practices. Fiber is a huge source of dust so corrugated boxes or cartons must be stored outside of any clean room.

Using approved equipment

Another important element in packaging in a clean environment is using appropriate equipment and furniture to ensure they do not generate micros or dust. Stainless steel tables are often required so that regular cleaning can take place without any fear of metal oxidation. Floors must not be deteriorated and ceilings must be able to handle water for complete wash downs as dictated by certain projects. Light fixtures must also be special and be water proof and shatter proof.

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Discussion (1)

  • James Harman

    Before global cleanroom classifications and standards were adopted by the International Standards Organization, the U.S. General Service Administration’s standards were applied virtually worldwide.