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.
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.
Protecting yourself from highly hazardous materials doesn't have to make you look out of this world.
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.
Biodecontamination using hydrogen peroxide (H2O2), a highly effective sterilant being used in the disinfection of packaging materials and in processes where sterilisation is required.
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.
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.
Current statistics show that one in three people have a life-long risk of developing cancer. There is little scientific evidence currently available relating to whether working with cytotoxic drugs actually increases the risk of developing cancer or not.