Success Through Sterilization - Considerations for Building a Clean Room Facility
Many pharmaceutical industry verticals — such as biotechnology, nutraceutical and medical device manufacturing —have clean room operations in place to ensure that all products that reach the market are safe for patient or consumer use. Following protocols to closely monitor environmental conditions in these aseptic manufacturing areas enables compliance with U.S Food and Drug Administration (FDA) regulations and eliminates unsterilized bacteria — otherwise known as controlling the product bioburden.
When developing a clean room program, it is important to make sure that the plan meets all regulatory requirements mandated by agencies such as the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO). After the regulatory framework is established, a manufacturer can select the proper monitoring equipment designed specifically to suit its operation.
Sampling Surface and Air
To collect meaningful data for analyzing the performance of the aseptic area, conduct environmental monitoring during normal clean room operations. Using contact plates and swabs for surface sampling are two effective ways to keep a close eye on potential contaminants. Contact plates are best used on flat surfaces, whereas swabs are effective in sampling switches and other irregular surfaces and components.
Manufacturers should also choose the best viable air sampler for the task at hand; whether it is R&D for a particular pharmaceutical compound or packaging for a medical device. The air sampler should be easy to disinfect and portable, yet sturdy, to allow for safe, quick relocation.
Personnel, environmental conditions and the proper selection of cleaning materials all play major roles in maintaining a properly decontaminated clean room. Lab employees should not only maintain good personal hygiene practices, but to minimize contamination potential, workers experiencing respiratory issues or skin irritations should be reassigned to alternate duties until the problem clears up.
Clean room temperature and humidity also should be closely monitored. If the room is too hot, workers may perspire heavily, increasing the risk of human flora contamination. On the flipside, if temperatures are too low workers may shiver, increasing the release of unwanted microbes into the air.
Proper selection of cleaning materials, equipment and cleaning agents should be appropriate to the type of cleaning required in the room. Chamois skin mops, urethane sponges, water soluble ceilings and wall and panel cleaners all help manufacturers control the clean room environment and keep it contaminant free.
Pharmaceutical manufacturers looking to find the right solutions to build a viable clean room must be certain their plans meet regulatory requirements and ensure sterile product manufacturing environments. Companies can find the insight and technologies to achieve this at Pharma EXPO (Nov. 2-5; McCormick Place, Chicago). Co-located with PACK EXPO International 2014, the event is jointly produced by PMMI, The Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will showcase the latest advancements for cleanrooms — as well as a wide range of solutions for pharmaceutical processing and packaging. Additionally, attendees in the pharmaceutical, nutraceutical, medical device and biotech industries can gain insights on best practices for efficient environmental monitoring and new industry regulations by leveraging the on-site educational programming.
To register for the event, visit Pharmaexpo.com.
PMMI, The Association for Packaging and Processing Technologies, is a trade association representing over 600 packaging and processing supply chain companies that provide a full range of packaging and processing machinery, materials, components and containers. PMMI actively brings buyers and sellers together through programs and events such as The PACK EXPO family of trade shows, packexpo.com, PMT Magazine, PACK EXPO Show Daily, networking events and educational programs.
PMMI organizes the PACK EXPO trade shows: PACK EXPO International, Pharma EXPO, co-located with PACK EXPO International and presented jointly with the International Society for Pharmaceutical Engineering (ISPE); PACK EXPO Las Vegas, PACK EXPO East, EXPO PACK México and EXPO PACK Guadalajara, connecting participants in the packaging and processing supply chain with their customers around the world. Coming Up: EXPO PACK México 2014, June 17-20 (Mexico City, Mexico); PACK EXPO International 2014, Nov. 2-5 (McCormick Place, Chicago); Pharma EXPO, co-located with PACK EXPO International 2014; PACK EXPO East, debuting Feb. 2–4, 2015 (Pennsylvania Convention Center, Philadelphia); EXPO PACK Guadalajara 2015, March 18-20, 2015 (Guadalajara, Jalisco, Mexico).
Learn more about PMMI and the PACK EXPO trade shows at PMMI.org and Packexpo.com.
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China and is publisher of Pharmaceutical Engineering Magazine. Visit www.ISPE.org for more information.