Graver's technology manages the risk of contaminants in healthcare applications, such as medical devices, cosmetics, diagnostics, and pharmaceutical agents.
The healthcare sector consists of a diverse group of applications that include medical devices, cosmetics, diagnostics reagents, biopharmaceutical agents, and ingredients to produce topicals, orals, and parenterals. With the increase in population and the increase in chronic as well as novel diseases, the development of advanced drugs, medications and treatments is critical to maintaining the health and safety of the populations in both advanced and developing countries. These highly regulated applications require high purity standards and highly controlled processes and environments to effectively manage the risk of particulate, microbiological contaminants, and dissolved materials that are derived from the manufacturing process or otherwise present health hazards if not removed. Management of people, processes, and materials by pursuing adequate preventive measures will help maintain high-quality standards while complying with statutory regulations.
Graver Technologies has been designing and producing superior filtration, separation and purification solutions for more than 100 years. Whether producing utility air, diagnostics, antibiotics or vaccines, Graver Technologies has a market solution. Our broad product offering provides for a cost-effective process to achieve consistent, high-quality product that meet the performance safety and regulatory demands in the application. Many healthcare products under development today will be produced by multi step synthetic processes requiring extensive downstream purification. Graver Technologies’ range of products include prefilters, polishing filters, bioburden, sterilizing grade filters, microfiltration and ultrafiltration tubular crossflow as well as proprietary adsorbent technologies, ensuring that the manufacture of products for the healthcare industries are safe and free of contamination.
Several essential applications for filters. Tank vent or fermentation feed air filters, the choice of which depends upon the specific method being used in the fermentation process, ensure that particles and microbes do not enter the process through air sources. These filters should utilize a hydrophobic membrane such as PTFE and have claims for sterility. A second area is to ensure that all fluids in the process are microbial-free, so filtration using a 0.2 micron hydrophilic membrane filter that is rated as sterilizing grade is commonly used. This would apply to water, nutrient broths or any liquid additive essential to the process.
Some of our the standard Certifications and Compliance Standards: ASME Code, Section XI, Division I Compliance, PED 97/23/EC Compliance, ISO 9001:2015 Certification, NSF 61 Certification, FDA Title 21 Compliance, USP Class VI Compliance, EU 1935 OML Compliance
Generally, HEPA filters are not intended to be washed and reused.
Ultrapure water (UPW), high-purity water (HPW) is water that has been purified to stringent specifications which may include microbial, particulate, and metal contaminants. The standards of water quality will vary significantly by application and industry. For healthcare applications, the USP (United States Pharmacopeia) has 8 different classifications, with the common classification for processing high purity water being Water for Injection (WFI) and Purified Water.
Medical devices can use a wide range of filter technologies. Graver focuses specifically upon use of PLEKX® technology for the removal and/or reduction of multiple odor, gas, fume and chemical contaminants in both doctors' offices and surgical suites.
Microfiltration technology is not effective in removing chlorine and fluorides in water. These are typically removed through use of carbon based adsorbent technology.
Contact the Regional Sales Manager responsible for your specific geography, which can be found on the website in the "Where To Buy" link, or email your request to [email protected]
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