Application and Technology News
Quality Assurance System
In the large scale production of medicines quality, is not achieved by accident. It is result of a carefully constructed quality assurance system. This system must ensure that each medicinal product conforms to its intended use.
Defects
A defect is an undesirable characteristic of a product. It is defined as a failure to conform to specifications or a unit of a product which contains one or more defects is called a defective.
RABS vs Isolators: Understanding the differences
During the last 2 decades, aseptic processing has advanced with the use of isolators and Restricted Access Barrier Systems (RABS) as a means of detaching the operator from "critical areas" thereby reducing potentials risks in products.
Feeling Alienated by Safety?
Protecting yourself from highly hazardous materials doesn't have to make you look out of this world.
Blow-Fill-Seal Technology and Isolators
Blow-fill-seal (BFS) aseptic processing is an advanced technology perceived to be a proficient and safe system in filling and packaging sterile pharmaceutical liquids and other related health products used in ophthalmic and respiratory condition management.
How Clean is Clean Enough?
Biodecontamination using hydrogen peroxide (H2O2), a highly effective sterilant being used in the disinfection of packaging materials and in processes where sterilisation is required.
Why isolators are still preferred when handling HPAPIs?
Handling HPAPIs is different from other active pharmaceutical ingredients. Specialized containment is required to protect workers, facilities, and environment from HPAPIs. Moreover, as applied to other pharmaceuticals, product protection from contamination and losses is also required.
Be SAFE in Handling High Potency APIs
A significant proportion of new drugs under development contain high potency active pharmaceutical ingredients (HPAPIs). The market of HPAPIs is increasing, with expected growth in the global arena of about $17.8 billion by 2018. However, due to its inherent cytotoxicity, HPAPIs present handling challenges.
