Mislabled raw material containers are the ultimate contamination-control mystery

by Hank Rahe

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Feeling lucky? This could be the motto for employees working in the incoming sampling area at a pharmaceutical manufacturer. This receiving area is the entry point for raw materials in the facility and is the first place individuals will come into contact with the hazardous potent substances used in the pharmaceutical production process.

Most manufacturers have installed operating procedures that require the sampling of incoming materials. This can be performed by simply opening the container and removing a small amount of material for analysis.

There are two possible outcomes once the container is opened. The first is that the material in the container is the correct material and consistent with the container label. The second is that the material is mislabeled and is a hazardous compound. Mislabeled containers are common, and errors range from the contents being the correct material but a different strength to contents that are totally different than labeled.

Companies have ready access to the Material Safety Data Sheet (MSDS) designed to give them some indication of the proper safety precautions to be used when handling all incoming materials. But most of the MSDS documents are inadequate in terms of information and guidance and are no help at all if the materials are mislabeled.

Typically the sampling area, used for extracting a small quantity of materials from the vendor's containers for testing, is adjacent to the receiving dock in order to keep the unapproved materials separate from the approved materials located in the warehouse. Many times the incoming sampling area is isolated from the main stream of operations. In most cases, this area is treated as an “island” in terms of technical support for emergency response.

Companies should conduct a potential hazard review to ensure that both personnel and incoming sampling facilities are not at risk due to a vendor's mistake. It is not uncommon for companies to receive thousands of different raw materials in a variety of different forms including solids, liquids and gasses. And each of these forms has the potential for a significant risk of exposure.

This risk review should include an assessment of the facility to ensure proper engineering controls are in place. This, in turn, provides protection levels greater than what would normally be employed in handling known materials.

This risk assessment should include information on the range of hazardous materials that are received by the company; an assessment of suppliers to determine potentially hazardous materials produced at the shipping and manufacturing sites; containment capabilities of the current engineering controls; and a list of back-up personal protective equipment that's available.

Emergency response plans should be reviewed, considering that exposure to an unknown hazardous substance is a possibility.

Developing a containment strategy requires an understanding of the hazard created by the materials, the quantity of materials present, and the potential for personnel exposure while interacting with the material. If there is a possibility of exposure to an unknown potentially hazardous material, then engineering control levels should be increased to reflect this risk by implementing higher levels of containment.

Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the healthcare industry, as well as four years in academia. He is an expert in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.


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