The manufacture of products for the healthcare industry utilizes a wide variety of molecules, extracts and formulations that must be safe, free of contamination, consistent and meet critical regulatory demands.
Graver Technologies’ range of products include prefilters, polishing filters, bioburden and sterilizing grade filters that meet these challenges and ensure reliable, high quality final products.
ACTIVE PHARMACEUTICAL INGREDIENTS
Chemically active substances used to treat, diagnose or prevent disease will require cost-effective clarification to remove particulate contamination used in the manufacturing process.
Recommended products:
Scepter crossflow membranes for high solids or aggressive conditions
PMC series pleated polypropylene for polishing carbon
Stratum C series melt blown for particle removal and DE/carbon trap
COSMETICS
Products that are derived from both natural and synthetic sources require optical clarity and in some instances, bioburden control and would include shampoos, deodorants, and toothpastes, in addition to skin moisturizers, cleansers, lipsticks, eye and face makeup and perfume.
Recommended products:
Stratum A melt blown series to provide effective optical clarity
PMA series pleated polypropylene media for particle removal and polishing for clarity
ZTEC B series Polyethersulfone membrane filters for bioburden control
QXL series pleated filters for capture of deformable particles common in natural extracts
DIAGNOSTICS
Reagents and chemicals that are intended to asses biologically derived samples to provide information in order to diagnose or treat diseases and demand a high degree of consistency from batch to batch.
Recommended products:
QMC series pleated polypropylene filters for membrane protection
GFC series pleaded microfiberglass for use as serum based prefilter
ZTEC B series pleated polyethersulfone membrane filter for bioburden control
OPHTHALMICS
These preparations may be sterile, liquid, semi-solid, or solids that may contain one or more active pharmaceutical ingredients intended for application to the eyes and require both particle and bioburden control.
Recommended products:
QMA series pleated polypropylene filters for particle removal and membrane prefilter
ZTEC B series pleated polyethersulfone filters for bioburden control
MBC/CMBF melt blown series for protection of downstream pleated filters
NUTRACEUTICALS
Products include nutrients, herbal products and dietary supplements that have a physiological benefit or offer protection against chronic disease.
Recommended products:
Scepter membrane to process high solids solutions
ZTEC B series pleated polyethersulfone membrane for microbial control at packaging
Stratum A series melt blown filter to produce visual clarity
USP WATER
The manufacture of pharmaceutical waters as defined by the United States Pharmacopoeia (USP) requires the removal or the reduction of the objectionable components to a tolerable level, followed by preserving the quality of the water thereafter.
Recommended products:
TefTEC and TefTEC V series pleated PTFE membrane for tank vents
Stratum A series melt blown to provide protection of membranes in high purity water systems
ZTEC P series polyethersulfone membrane filters to meet requirements for sterility
SMALL VOLUME PARENTERALS
Substances produced by means of cell harvesting, protein isolation and recovery or protein synthesis and are among the most regulated and validated products.
Recommended products:
ZTEC P series pleated polyethersulfone membrane for final sterile filtration of product
QMA series pleated polypropylene for optimal protection of the sterilizing grade membrane
Scepter crossflow membranes for post fermentation cell harvesting
LARGE VOLUME PARENTERALS
Sterile drug products that are typically emulsions, suspensions or reconstituted powders and are required to be essentially free from particles and microbiologically safe.
Recommended products:
ZTEC P series pleated polyethersulfone membrane for final sterile filtration of product
TefTEC series pleated PTFE membrane for tank vents
ZTEB B series pleated PES membrane as prefilter to sterilizing grade filter or high level particle control
Graver’s quality system has been certified to meet ISO 9001 standards. Final membrane filters are rinsed with ultrapure deionized water and integrity tested prior to release. Complete traceability is ensured by the engraving of lot numbers on all filters, plus pore size identification on membrane fiters to assist customer installation accuracy. Membrane filters are flushed with ultrapure water, tested and packaged in an ISO Class 7 cleanroom.