Finding your way within regulated industries
After reviewing state and local regulations governing life sciences facilities, operations and record-keeping, I can say there is great disparity in understanding of the need for contamination control during the preparation of sterile products.
by Hank Rahe
Industries under the life sciences umbrella are all subject to regulations imposed at either the federal or state level. The delivery of parenteral products, by both institutional and retail pharmacies, is regulated by state boards of pharmacy throughout the United States. Each state, the District of Columbia and individual commonwealths have their own regulations and enforcement.
In these regulations, you`ll find little direction on the physical facilities that provide for the protection of the product and personnel, with the exception of one state — New Jersey. An effective description of methods of sanitizing, the second key element to providing an acceptable aseptic manipulation facility, is almost non-existent.
Contamination control technology has significantly improved the ability to deliver products with an increased sterility assurance level. Is this effort wasted by the lack of understanding and control at a key link in the delivery chain?
Some states have no regulation or definition of the facilities for preparation of sterile products in the pharmacy, while others have only a few general statements. This lack of definition, along with the lack of technical support in the area of contamination control, results in a potential for increased nosocomial infection in the patient population. There are no controlled studies available, defining the social and economic impact that improved contamination control would have, if they were implemented.
The American Society for Health System Pharmacists (ASHP) has written a voluntary guidance document called Technical Assistance Bulletin on Quality Assurance for Pharmacy — Prepared Sterile Products. The document provides some definition for facilities and equipment. It also provides guidance for aseptic manipulation based on a “risk level” associated with product type, storage conditions, length of storage before use, and single or multiple patient use.
Risk level I calls for a Class 100 environment for the manipulation of products but has no limitations on the surrounding environment. Risk level II recommends a Class 100,000 surrounding environment and risk level III, a Class 10,000 surrounding environment.
Processing recommendations are focused on the length of time before use and the storage conditions. Could it be that if you administer a contaminated product quickly enough after contamination, it won`t have a negative effect? Or if so, the effect will not be associated with taking the product?
Risk level III recommendations for facilities follow sound aseptic practice. However, sanitizing recommendations leave room for improvement. Common practice in aseptic preparation of parenteral products in the pharmacy setting typically calls for the use of 70 percent isopropyl alcohol. Sometimes, rotation of sanitizing agents is mentioned, but few alternatives are listed. If these recommendations are to be effective, they must clarify the need to sterile filter any sanitizing agents, and they must emphasize adequate residence time of the agent to achieve the desired result.
Yet despite these shortcomings, congratulations to ASHP for bringing needed information to this area of life sciences.
The National Association of Boards of Pharmacy also publishes a document. Model State Pharmacy Act and Rules is supposed to provide state pharmacy boards with an example. This document lacks the facility and sanitizing details necessary for a functional, aseptic manipulations area.
Do your state`s regulations allow preparation of parenteral products on a counter in the local hospital pharmacy or clinic?
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years` experience in the healthcare industry, as well as fours 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.