By Sterling Kline, IPS
Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional cleanroom facilities of the 20th century are being rapidly replaced with advanced barrier-based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients.
By Dr. Kevin Ward, Biopharma Technology Limited The imperative for successful generic production is ruthless management of production costs within a large scale manufacturing process that achieves robust, replicable, and dependable results. The competition for market share amongst generic manufacturers means that there is no place for inefficient process within the profit margins expected in this sector of activity. The generic manufacturer must ask three key questions.
By Hermann Carbone, Bonfiglioli Engineering SPA Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However, the process also relies on machines and machine operators, whereby misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging, thus allowing air and moisture to enter the blister and damage the product.
By Kathie Clark, Wingspan Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision making, we've researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick, ThermoSafe, Sonoco Protective Solutions Bulk transportation of temperature-sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. This imperative has prompted pharmaceutical companies to look at more efficient and economical means of temperature-controlled distribution. Passive packaging systems are one of the proven and repeatable methods for international bulk shipments of temperature-sensitive products.
By Rick Dobson, AES Clean Technology You have been tasked by senior management to look into purchasing a cleanroom environment for a possible new product line. The mandate is that the cleanroom system provider must guarantee temperature, humidity, pressurization, and classification. As with any purchase, it is always best to be an educated buyer and have researched the options available to you. Knowing what questions to ask and what the cumulative effect is from the answers will make for a sound decision process and an overall successful project.
By Gary Partington, Walker Barrier Systems Isolators have been around the pharmaceutical industry since the early 1980s and in the nuclear industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product.