What is USP Class testing?
USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. USP Class Testing standards are determined by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for the quality and safety of medical devices and foods.
What is USP Class VI plastics?
USP Class VI refers to one of the six designations for plastics from General Chapter <88> of the United States Pharmacopeia and National Formulary (USP-NF). This chapter provides guidelines for testing and certification of a material to be used within a medical device.
What is a Class VI material?
By ensuring that a material is non-toxic and won’t result in immunological rejection, biocompatibility testing ensures that a rubber is safe for use with living tissue. Examples of these materials include the medical silicones used in stents and catheters.
Is polypropylene USP Class VI?
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 USP 88 Class VI?
What is USP CLASS VI? USP 88 is designed to determine biological response of animals to elastomerics, plastics, and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test.
Is PTFE USP Class VI?
Primarily biopharmaceutical manufacturers use USP Class VI for their process equipment. Sterile and diaphragm valves have USP Class VI PTFE material in them, and sanitary pumps require Class VI O-Rings and sealing material.
What is the difference between polypropylene homopolymer and copolymer?
Propylene homopolymer has a high strength-to-weight ratio, and is stiffer and stronger than the copolymer. Polypropylene copolymer is a bit softer but has better impact strength. It’s tougher and more durable than propylene homopolymer.
What is biological reactivity?
Biological Reactivity Tests, In Vivo are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test.
Is PTFE biocompatible?
PTFE has been shown to be biocompatible, and it maintain its integrity during and after implantation. Some PTFE membranes are even combined with structural elements such as titanium [9].
Is FEP biocompatible?
PTFE, FEP and PVDF are well established biocompatible materials, and their lubricity and chemical resistance make them the material of choice for products such as multi lumen tubing and others that are used in minimally invasive procedures. PTFE and PVDF are among the few polymers used for filter membranes.
What is copolymer example?
A copolymer is a polymer that is made up of two or more monomer species. Many commercially important polymers are copolymers. Examples include polyethylene-vinyl acetate (PEVA), nitrile rubber, and acrylonitrile butadiene styrene (ABS). A homopolymer is a polymer that is made up of only one type of monomer unit.
What is homopolymer give example?
Homopolymer is that polymer which is made up of only one type of the monomer whereas on the contrary co-polymers are those which are made up of two or more types of monomers. Examples of the copolymers are as nylon-6,6,Buna-S, polyesters, Bakelite, melamine formaldehyde etc. and so on.
How does the USP test for toxic reactivity?
Testing is commonly done as per USP <88>, which requires three types of testing: systemic injection, intracutaneous, and implantation. Test specimen are injected with the extract intravenously and observed for 72 hours. The specimen are monitored for any abnormal toxic reactivity. The scientist determines the test as pass/fail.
How are in vivo tests used to classify plastics?
There are three in vivo tests involved in the classification of plastics. The Systemic Injection Test and the Intracutaneous Test are designed to determine the systemic and local biological responses to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.
What does the USP Class testing I-VI Mean?
USP Class Testing I‑VI The US Pharmacopeia-National Formulary (USP/NF) provides standardized methods and specifications for generic pharmaceutical raw material and finished products.
What does USP stand for in biological reactivity?
USP <87> In-Vitro Biological Reactivity – Cytotoxicity Testing Cytotoxicity tests are in-vitro assays used to assess the possibility of a test article to cause the death of cells in culture or to prevent their multiplication.