Compliant cGMP Consumables: Sterile Cleanroom Products For 503A/B
cGMP consumables including sterile cleanroom apparel and cleanroom cleaning supplies for Current Good Manufacturing Practice compliant pharmacy clean rooms. Our pharmaceutical manufacturing clients that adhere to cGMP rely on us to stock their sterile apparel and clean room cleaning chemicals and tools. cGMP is the most up-to-date protocol and requires a sterile environment. We supply cGMP-compliant patient-specific 503A pharmacies and 503B outsourcing facilities with all of the required sterile cleaning supplies, sterile apparel and other specialized sterility assurance products needed for compliance.
At other cleanroom suppliers, sterile cleanroom consumables are often backordered resulting in long delivery times that challenge your cleanroom staff’s ease of operating in your critical environment. We stock a full selection of sterile coveralls, cleanroom gloves, lint free alcohol wipes, disinfectants, and other required consumable products for cGMP compliance. We hold stocks of your favorite products to ensure you are not affected by backorders. Our pharmacy outsourcing facility customers rely on us for weekly deliveries of all their sterile cleanroom products.
Our cGMP industry experts are available to specifically discuss your facility and the correct cleaning and maintenance SOP (Standard Operating Procedure). Our cGMP cleaning products are used for equipment and environmental surface cleaning, controlling and cleaning spills, applying and removing disinfectants and cleaning isolators. Read about cGMP Cleaning for Pharmaceutical Manufacturing Cleanrooms.
VAI Veltek 1700 series sterile cleanroom boot covers come with an anti-skid bottom. These sterile overshoes are knee height, have a tie top, and elastic ankle for a snug, secure fit. The Easy2Gown folding and packaging on this cleanroom boot cover simplifies aseptic garbing procedure. These boot covers are ISO5 Class 100 compliant, individually packed, and both fluid and dry particle resistant. Gamma-irradiated to 10-6 sterility assurance.
Sterile
Knee-height, tie top, elastic ankle
Anti-skid gray bottom
For use in Class 100 ISO5+ Cleanrooms
Individually packed pairs in Easy2Gown donning packages
VAI Veltek 1700 series sterile frocks are made using a microporous (MP) coated material and comes with a zipper front closure. These sterile frocks have elastic wrists. The Easy2Gown packaging on this frock helps simplify aseptic garbing procedure. This item is ISO5 Class 100 compliant, individually packed and is both fluid and dry particle resistant. Gamma irradiated to 10-6 sterility assurance and specially folded to achieve proper aseptic gowning via the Easy-2-Gown method.
VAI Veltek 1700 series Easy 2 Gown Hoods are are made with protective microporous (MP) coated material and available with or without a built-in facial mask. This high-quality unique sterile garment allows full facial coverage with the attached mask. Simply wear goggles to achieve full facial coverage. This item is ISO5 Class 100 compliant, individually packed and is both fluid and dry particle resistant. Gamma irradiated to 10-6 sterility assurance and specially folded to achieve proper aseptic gowning via the Easy-2-Gown method.
VAI Veltek 1700 series sterile sleeve protectors come with an integrated thumb-loop. These sterile sleeve have elastic ends and are made with protective microporous (MP) coated material. The Easy2Gown packaging on these sterile clean room disposable sleeves helps simplify aseptic garbing procedure. This item is ISO5 Class 100 compliant, individually packed and is both fluid and dry particle resistant. Gamma irradiated to 10-6 sterility assurance and specially folded to achieve proper aseptic gowning via the Easy-2-Gown method.
VAI Veltek 1800 series Easy 2 Gown Hoods are are made with highly breathable, puncture-resistant SMS material. It is available with or without a built-in facial mask. This high-quality unique sterile garment allows full facial coverage with the attached mask. Simply wear goggles to achieve full facial coverage. This item is ISO5 Class 100 compliant, individually packed and is both light fluid splash and dry particle resistant. Gamma irradiated to 10-6 sterility assurance and specially folded to achieve proper aseptic gowning via the Easy-2-Gown method.
These human serum albumin (HSA) vials are sterile diluent for allergenic extracts injection to preserve allergen stability. The albumin saline solution contains .9% sodium chloride, .03% normal serum albumin .4% phenol, & WFI. Packaged in Type 1 borosilicate vials with non-latex butyl stoppers in a FDA-monitored ISO5/Class 100 cleanroom using cGMP best practices.
All vial sizes available in a silver cap; 4ml, 4.5ml, and 9ml are also available in blue, gold, green, orange, pink, purple, and red caps. See ordering key in images for case quantity. Use the colored vial caps for easy identification of products.
.9% sodium chloride, .03% normal serum albumin .4% phenol, & WFI
Type 1 borosilicate vials
Silver cap on all vial sizes; blue, gold, green, orange, pink, purple, and red caps available in sizes 4ml, 4.5ml, and 9ml
cGMP-compliant
Latex-free butyl stoppers
Sterility, depyrogenated, and endotoxin certificates available upon request.
Alcoh-Wipes individually packed alcohol wipes are pre-saturated with 70% USP-grade isopropyl alcohol along with WFI, water for injection. These wipes are individually wrapped, with 100 wipes per case. These wipes are made of polyester which is the cleanest of all lint-free wipe materials and is available in your choice of 6”x6”, 12”x12” and 18”x18” sizes.
The ALK amber vials are amber-colored type 1 borosilicate glass vials assembled with latex-free chlorobutyl stoppers. 13mm and 20mm base diameter vials available. See our clear sterile empty vials and clear vials with FluroTec stoppers. Manufactured and packaged in a FDA-monitored ISO5/Class 100 cleanroom under cGMP conditions. See ordering key in images for case quantity.
13mm and 20mm diameter vials available
Amber-colored Type 1 USP borosilicate glass
Sterile
cGMP-compliant
Latex-free stoppers
Sterility and endotoxin certificates available upon request.
PurGuard SV800-AF sterile goggles are reusable, fully autoclavable and for use in aseptic critical environments. They features a standard width view along with an special anti-fog coating. The unique ventilation design helps prevent fogging. Users like the PurGuard sterile goggles due to the wider overall fit and soft frame material.The adjustable silicone headband and special lens material are resistant to disinfectants and most cleaning chemicals. The SV800-AF features direct ventilation at the top and indirect ventilation at the bottom.
PurGuard SV900 anti-fog autoclavable cleanroom goggles are reusable and fully autoclavable. The ventilation design along with the special antifog coating effectively prevent fogging of the lens. This model is characterized by a panoramic lens allowing a wide all-round vision. The tested and certified PurGuard goggles were developed for critical environments and offer optimal protection both for wearer and the environment. 40 autoclave cycles showed minimal wear on these goggles.
BioClean BUPS Ultimate sterile polychloroprene gloves provide excellent chemical resistance and anti-static properties. This material offer amazing tactility and grip similar to latex for working with delicate or small items. These gloves are powder-free, latex-free and suitable for use in ISO3-5 Class 10-100 critical environments. They are a popular sterile chemo glove and are ASTM D6978 rated for USP 800 compliance. See our other polychloroprene cleanroom gloves or catalog for our full line of BioClean apparel and gloves. We also have sterile gloves in other materials.
BioClean BDBS-G sterile pouch masks with attached neck guard come individually wrapped with 200 masks per case. This unique mask offers complete skin coverage from the nose to chest. This mask is Class 10 ISO3 compliant as well as cGMP-compliant. They have a bendable encapsulated nose piece and are gamma irradiated with sterility assurance level of 10-6. The hydrophobic outer layer ensure the mask stays dry inside.
BioClean Emerald BENS sterile nitrile cleanroom gloves are one of our most-requested gloves. These green nitrile gloves come in cases of 200 individually packed pairs and are very popular for chemotherapy handling and USP 800 compliance. They are great for double-donning and their green color give them visual appearance. These gloves are ISO3-5 Class 10-100 compliant for the most critical of clean room areas. See our other nitrile cleanroom gloves or catalog for our full line of BioClean apparel and gloves. We also have sterile gloves in other materials.
BioClean BPZS P-Zero sterile polychloroprene cleanroom gloves provide excellent chemical resistance with anti-static properties. The polychloroprene (neoprene) material with textured fingertips offers amazing tactility and grip for working with delicate or small items. These hand-specific fit gloves are powder-free, latex-free, and suitable for use in ISO3-5 Class 10-100 critical environments. They are a popular sterile chemo glove and are ASTM D6978-rated for USP 800 compliance.
Sizes from 6.0 – 9.0
200 Pairs Per Case: One pair per inner EasyTear pouch, 10 pouches per sealed outer sterile bag; 20 outer bags per lined carton
Class 10-100 ISO3-5
12″ length for good wrist protection from splash
Natural color
Gamma-irradiated with accompanying certificate of sterility
BioClean VFM210 sterile face masks with attached face shield come with 100 individually wrapped masks per case. These masks feature your choice of four-tie attachment or head-loops with blue plastic clips that attach behind your head. This is a wider mask than most cleanroom masks at 8.5″. This mask features high bacterial, viral, and particle filtration and is cGMP compliant. They feature a bendable encapsulated nose piece for a perfect seal. These masks are gamma-irradiated with sterility assurance level of 10-6. See our catalog for a full line of BioClean facemasks for cleanrooms.
True Care Biomedix sterile cleanroom coveralls come with an attached hood and boot covers. These sterile cleanroom suits are tested for use with chemotherapy by testing standard ASTM D6978-05. These economical sterile coveralls come in sizes small, regular, x-large and 3x-large. These sterile coveralls are economically priced and great quality. Many pharmacists wear these under their True Care sterile chemo gowns for complete protection.
