What is USP Class VI?
USP Class VI refers to a set of biocompatibility testing requirements from the U.S. Pharmacopeia (USP), a non-profit organization whose standards inform decision-making at the U.S. Food and Drug Administration (FDA).
What is the difference between USP Class VI and ISO 10993?
For example, USP Class VI requires an intracutaneous irritation test, which is also required for ISO 10993 compliance. However, Class VI also requires subacute toxicity and implantation effects, which are not required for many categories of ISO 10993. It also misses required tests associated with other categories.
Is PTFE USP Class VI?
It is hereby confirmed that representative samples manufactured with Dyneon™ TFM™ PTFE have been certified in accordance with USP protocol (USP Class VI – 70°C, Toxikon Corporation – USA, Report # 98G-2147, dated 11/06/98). The test articles meet the requirements of USP 23, 1995, for Class VI Plastics – 70°C.
Is PFA biocompatible?
FLUOROPOLYMERS AND BIOCOMPATIBILITY Fluoropolymers have among the best biocompatibility of all plastics. Class VI USP approved fluoropolymers include ETFE, FEP, PFA, PTFE, and PVDF, to name but a few representatives from this group.
What is USP IV?
The USP IV is a well-established standardised flow-through dissolution system that has also been extensively used to assess the drug release pattern from extended-release formulations (14–16). It has also been increasingly used to study release pattern from microsphere and film-based systems (17–19).
What is systemic injection test?
Systemic injection testing is designed to determine the systemic biological responses of animals to plastics (or other polymers) by a single-dose injection of sample extracts from medical devices or therapeutic products. Systemic injection testing and intracutaneous testing may be performed using the same extracts.
What is the difference between medical grade and food grade?
Food grade silicone is a type of silicone that is safe for use with foods. Medical grade silicone is tested for bio-compatibility and is appropriate to be used for medical applications and must meet certain high standards of manufacture, bio-compatibility and safety, e.g. EU Regulation 2017/745 (MDR) or ISO 10993.
How many drugs are in USP?
The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients).
What is meant by biocompatible?
Biocompatibility is a general term describing the property of a material being compatible with living tissue. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids.
Is ABS plastic biocompatible?
As mentioned above ABS plastic is biocompatible and recyclable material.
Is polypropylene USP Class VI?
Medical Grade Polypropylene Our USP class VI polypropylene is 100% virgin medical, lab and food grade and is even autoclave sterilizable. This material is also BPA, Lead and heavy metal free, phthalates safe and is REACH, RoHS, DMF and FDA compliant.
What is dissolution and types?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
Which is the highest USP Class for biocompatibility?
Biocompatibility is historically referring to the USP class VI ( United States Pharmacopoeia) for testing, where class VI represents the highest class. In particular, regarding the USP class VI certification process, materials have to pass the biological tests, i.e. In vivo testing, USP <88>.
What does USP Class VI Mean in medical molding?
As an experienced medical molder, The Rubber Group works with independent laboratories like NAMSA to understand these requirements. USP Class VI refers to a set of biocompatibility testing requirements from the U.S. Pharmacopeia (USP), a non-profit organization whose standards inform decision-making at the U.S. Food and Drug Administration (FDA).
Which is more rigorous USP Class VI or ISO 10993?
USP Class VI Testing is only one standard of biocompatibility, however. Though not a limited series of tests, some biocompatibility requirements for medical devices may exceed the testing performed in USP Class VI. A more rigorous standard for the biological evaluation of medical devices is ISO-10993.
What are the methods of USP Class VI testing?
USP Class VI Testing Methods. USP Class VI testing is conducted by producing an extract of the product with different extraction fluids, such as polyethylene glycol and vegetable oil, and injecting it in specimen (rabbits and mice) in vivo (alive), to observe the biological response to the extract.