What is a sterile injectable?
The generic sterile injectable refers to biologics that are used for the treatment of various drugs and has same active ingredients to that of the branded versions of it, however the inactive contents of the drugs can be varied..
What is the difference between aseptic and sterile?
The difference between “aseptic” and “sterile” is not always properly understood. … Aseptic means something has been made contamination-free, that it will not reproduce or create any kind of harmful living microorganisms (bacteria, viruses and others). Sterile describes a product that is entirely free of all germs.
What is aseptic filling?
Aseptic filling is an aseptic process that requires the close coordination and complex interaction between personnel, sterilized product, the fill/finish equipment system, cleanroom and support facilities, and sterilized filling components.
What is sterile API?
A sterile API is an API that has been subjected to additional processing steps to remove micro- organisms, particles and/or endotoxins. Aseptic processing.
What is hot filling process?
Hot filling is the process of sterilizing the product and inside of a bottle or container and cap or closure in order to ensure the safety of the product and prolong its shelf life. … This process will allow for a longer shelf life, resulting in fewer discarded products.
Is PET heat resistant?
PET bottles do not have as high of a temperature resistance (less than 131°F) as HDPE. PET containers can also handle cold temperatures of about -40°F.
Can PET bottles be hot filled?
The short answer is no, you cannot. It’s a shame because PET bottles can have the look of a quality glass, bringing elegance to a product and adding market value because it looks so good and is lighter to transport than glass. However, standard PET plastic is not suitable for normal hot fill.
What is heat set PET?
The Basics of Heat Set Technology. PET is a semi-crystalline thermoplastic, which softens at approx. 76°C (what is called “Glass Transition”). Above this temperature, the material becomes elastic, and can be formed, a property utilized effectively in the Stretch Blow Molding process.
What is the definition of a sterile product?
Reply(by Keith): “Sterile products” refers to products that are going to be administered using an enteral route of administration. The “products” are going to be infused directly into the bloodstream or body tissue, it is extremely important they be “sterile”.