Can performing tests and sharing outcomes help to build a common approach and standard that will begin to standardize this important containment protective measure?
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.
The sterilizer type ADV, is designed for use in the pharmaceutical and biotechnological industry for production, laboratory and R & D applications.
The sterilizer type SDR, is designed to sterilize liquids in open, semi sealed or 100% closed containers according to the steam-air mixture process.
The safe and reliable sterilization and depyrogenation of pre-cleaned containers is the most important pre-treatment step in the pharmaceutical process.
Thermolab Scientific Chambers are perfectly designed for the high requirements of stability studies and climatic tests. With Stability Chambers specifically developed to meet FDA/ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Thermolab Stability Chambers feature various safety feature, audio visual alarms, 21 CFR part 11 software and a vast range of options and is the most preferred choice for stability studies. Every Thermolab Scientific Chamber repeatedly produces required conditions, structural integrity that keeps the chamber working properly through years of demanding test cycles and measuring equipment’s that precisely records all test data.
Thermolab Cooling Cabinets are of superior quality and precise control best suited for storage of reference standards, raw materials and vaccine storage. Thermolab Cooling Cabinets feature various safety feature, audio visual alarms, 21 CFR part 11 compliant software and are the preferred choice in cooling solutions.
Thermolab’s Oven provides heated conditions for curing, drying and exposures for high temperature testing with high accuracy and superior quality.
Walk-In BOD Incubator (Bio-Oxygen Demand) are used to maintain temperature for test tissue culture growth, storage of bacterial cultures and incubation where high degree of constant temperature accuracy is required. Thermolab BOD Incubators provide with accurate conditions and uniformity throughout the chamber.
Thermolab Scientific Chambers are perfectly designed for the high requirements of stability studies and climatic tests. With stability rooms specifically developed to meet FDA / ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Our chambers feature automated process control, energy efficiency and a vast range of options and are the most preferred choice for stability studies. Every Thermolab Scientific Chamber repeatedly produces required conditions, structural integrity that keeps the chamber working properly through years of demanding test cycles and measuring equipment’s that precisely records all test data.
