Processes for the Inspection of Cleaned Equipment in the Pharmaceutical Industry to Evolve
When it comes to the inspection of cleaned equipment of pharmaceutical manufacturing equipment, there are currently no industry-mandated standards. Instead, various companies have had their own internal procedures for inspecting cleaned equipment, with visual inspection widely used as the primary method. While visual inspection continues to be a useful technique, allowing for quick evaluation to help minimize downtime between product batches, pharmaceutical companies looking to evolve and expand their inspection processes can look to alternative technologies and a new resource for guidance.
Used for decades, visual inspection remains the most commonly employed technique for evaluating the cleanliness of equipment in low-risk applications. Aspects to take into consideration when inspecting cleaned equipment include the specific tools that should be used, the appearance of residue that could be present, and the corresponding visual appearance of aging material.
More than meets the eye
Visual inspection of cleaned equipment has been utilized for decades; however, calls for more comprehensive inspection techniques may drive the advancement of current practices and the adoption of new methods. This movement is driven by industry players who assert that external factors such as color blindness and lighting conditions can affect inspection done with the naked eye. Additionally, industry regulators expect to see data to back the validation of equipment, something that visual inspection alone cannot provide.
Other inspection techniques exist for applications that fall outside the scope of low-risk applications that require only a visual evaluation. For example, total organic carbon analysis (TOC) applied for higher-risk applications – or the more specific high performance liquid chromatography (HPLC) – may be necessary.
The re-use of equipment frequently requires the application of portable laser scanners that can quantify the contamination levels on the surface of equipment and prevent cross-contamination between batches of different products. This method does require patience on the part of the manufacturer as the laser analysis does not produce results instantaneously for rapid changeover.
Expanding inspection practices
By expanding and standardizing inspection and cleaning validation activities, the pharmaceutical industry can save time and become more confident in the quality of equipment.
The International Society for Pharmaceutical Engineering (ISPE) is set to release a guide for equipment inspection this summer. As the first of its kind, the ISPE Baseline® Guide: Science and Risk-Based Cleaning Process Development and Validation, will help pharmaceutical manufacturers fine-tune visual inspection practices as well as other methods to ensure product quality and safety by providing guidance on inspection for:
• Use based on the level of risk;
• Use to support risk assessment;
• Development and validation as a sampling and analytical method;
• Qualification for verification and validation of cleaning;
• Use for parametric release of equipment;
• Use as an application of PAT;
• Training requirements for operators and inspectors; and
• Use as an element of a cleaning control strategy.
Pharmaceutical manufacturers can further explore inspection solutions at Pharma EXPO 2014 (November 2-5; McCormick Place, Chicago, IL). Co-produced by PMMI, The Association for Packaging and Processing Technologies, and ISPE, Pharma EXPO will present a world-class educational conference that will offer insights on visual inspection and new trends in the industry. Both Pharma EXPO and the co-located PACK EXPO International will feature displays of visual inspection technologies.
To learn more about Pharma EXPO and to register, visit pharmaexpo.com.
PMMI, The Association for Packaging and Processing Technologies, is a trade association representing over 650 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. 16–18, 2015 (Pennsylvania Convention Center, Philadelphia); EXPO PACK Guadalajara 2015, March 10-12, 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 Frankfurt, Germany and Shanghai, China and is publisher of Pharmaceutical Engineering Magazine. Visit www.ISPE.org for more information.