Sampling incoming materials and components
Pharmaceutical and medical device companies are subject to the regulations developed and monitored by the U.S. Food and Drug Administration. One of the recently revised regulations is “Current Good Manufacturing Practice for the Manufacture, Packaging or Holding of Drugs” 21CFR — Parts 210 & 211, which was revised as of November 4, 1998.
By Hank Rahe
Medical device manufacturers of certain types of products, such as catheter flushes, even though they are manufactured under a 510K, fall under both medical device and drug regulations.
A recent review of the revised cGMP guideline brought to mind an area frequently cited by the agency for non compliance — the sampling of incoming materials and components.
Quality control is generally responsible for the collection, testing, disposition and documentation of the many materials that are used in manufacturing and packaging drugs or device products.
Contamination control is essential during the operations involved in monitoring the quality of the product, both for component integrity and personnel protection. Such operations as sampling of components and material, require a well thought out facility, defined methods and documentation to achieve compliance.
The location of the facility used for collection of samples of the incoming materials presents a challenge in protection of both the material to be sampled and the personnel involved. In most cases, the area is located on or near a receiving dock within the warehouse. This area is generally busy, with internal and external personnel traffic, as well as material handling equipment.
The normal sampling program consists of the removal of a small quantity of material from the incoming containers. Personnel involved in sampling the incoming materials are required to obtain these samples from a number of containers. The number of containers sampled is determined by a statistical formula, the square root plus one, of the number of containers received. The containers vary in type and volume and can include bags, boxes, drums and bulk containers. The contents of the container is identified by an external label. However, there is still the potential for a mix up by the supplier that could lead to an exposure to harmful materials. Personnel working in this area need to be acutely aware of product Material Safety Data Sheet information and emergency spill control procedures.
Because of the large number of materials and the need to open the containers to obtain materials for sampling, there is also a high risk of cross contamination in this area. Facility design should incorporate controlled environments that facilitate cleaning and protect personnel and external environments.
The sampling area should be an integrated system. Such a system is required to handle a variety of materials ranging from sterile components to simple excipients. The system must consider cleaning, decontamination, sampling techniques, sample containers and the preparation of samples for transport to the testing facility.
As stated before, the incoming materials are received in a variety of container types and sizes and in most cases, the company cannot specify a particular type of packaging. This lack of control of the incoming container makes it difficult to design the direct environments in which the sampling takes place. The facility used for incoming sampling should contain several sampling workstations, with containment capabilities consistent with the hierarchy of technologies, which defines the capabilities of the different contamination control technologies. The selection of which contamination control environment to use for a specific material should be based upon exposure levels defined in the Material Safety Data Sheet.
In next month`s column we will continue the path that samples follow through preparation and testing.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years` experience in the healthcare industry. 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.