There exists two key methods for controlling serious outbreaks of transmissible diseases: therapeutic countermeasures and transmission control through isolation and containment.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.
The team at Polypeptide Labs' overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilized polypeptide product offloaded from a separate isolator.
Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.
Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for Conductivity apply to WFI Water produced on site for manufacturing purposes.
Restricted Access Barriers (RABs) were developed to enhance pharmaceutical aseptic processes carried out in conventional clean rooms. Extract Technology customer RABs are designed to fully comply with our customers’ requirements for aseptic pharmaceutical processing.
At a time when pharmaceutical manufacturing operations are under tremendous pressures to improve effectiveness, deliver quality and reduce costs, CRB's aseptic processing experts are creating innovative solutions for the handling of potent and non-potent compounds in aseptic environments.
For cost-effective implementation of containment requirements Mediseal relies on fast, optimal cleaning of pharmaceutical equipment.
The trend towards small lot sizes has negative effects for the pharmaceutical industry. Up to 30% losses in terms of overall equipment effectiveness (OEE) are not a rarity.
The FOF steam sterilizer series is the synthesis of Fedegari’s approach: work hard to create simplicity to you, without compromising performance. Fedegari guarantees the highest performances thanks to its experience and daily work with customers: engineering solutions, developing software and components.
The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.
The FCIS pharmaceutical isolator have been designed primarily for :
Emerson's Cascade Technologies is the global leader of packaging leak detection systems for the Aerosol, Food, and Pharmaceutical industries. The Cascade CT2211 aerosol microleak detection system is the first Quantum Cascade Laser (QCL) system developed for automated, in-line leak detection.
