The Pharmaceutical industry has always been a risk-based environment; the newly released ISPE OSD Baseline Guide has an entire chapter dedicated to risk management from both a quality and a safety standpoint. The following is a brief discussion of potential risks and how utilizing single-use containment devices, bags, and liners can greatly mitigate and eliminate contamination risks in the manufacturing environment.
The risks associated with highly potent, cytotoxic, and hormonal products can typically be broken into two major categories: personnel risk and product risk.
Personnel Risk: Does the combination of this product and the designated operations present a potential risk to the operator?
Product Risk: Does this product, the equipment cleaning philosophy/methodology, and the potential residual material on the product contact surfaces present a possible risk of cross-contamination?
The three primary sources of these potential risks are mechanical transfers, airborne transfers, and retention transfers.
A retention transfer refers to a residual concentration level of a specific material that falls above an established acceptable surface limit—a quantity that could result in a cross-contamination when manufacturing another product using the same equipment or transfer piping/system. Utilizing single-use bags, single-use isolators, and continuous liners in lieu of rigid container, equipment, or piping eliminates the cleaning requirement and effectively removes the chances of retention as a source of contamination from that part of the process.
An airborne transfer refers to a concentration level of a specific material in the air that, if it makes contact with an operator’s skin or is inhaled by an operator, is at a level higher than the safe exposure limit and could elicit an unwanted response. Also, it refers to an airborne concentration of the material that, upon contact with a piece of equipment or container, would result in a subsequent surface limit that could result in cross-contamination. Eliminating open processing, utilizing disposable bags in the material handling of ingredients, utilizing single-use liners for material transfers, and utilizing soft wall isolators around functional operations that by their nature cannot be made into a closed operation, will help eliminate—or at a minimum mitigate—the chances of an airborne contamination.
A mechanical transfer is the physical transfer of material via direct contact. Examples include material on operator gloves, material on operator booties, and material on external equipment surfaces. This type of transfer and risk is usually a consequence/result of a previous retention or airborne exposure to an operator. Once an operator (or portable piece of equipment) has been contaminated or is retaining residual material, it can move through the facility and make contact with additional people or equipment, and propagate the risk throughout the manufacturing environment.
By properly leveraging single-use containers, disposable material transfer methods, and flexible isolation technology, pharmaceutical manufacturers can reduce risk and eliminate or minimize their cleaning requirements.
(Source: IPS – Integrated Project Services, LLC)