New Sterile Cleanroom PPE For USP 800 Compliance - Pharmaceutical Technology
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New Sterile Cleanroom PPE For USP 800 Compliance

With the US Pharmacopoeia (USP) 800 compliance deadline coming up this year, many cleanroom operators are scrambling to find the proper sterile cleanroom products.

When working inside a cleanroom, the required personal protective equipment will be different than for nurses and general healthcare workers. It is vital to understand that specially made products and apparel for cleanrooms must be used, and not general medical grade gowns, gloves and other items. It is even more important to be using the right cleanroom products when working in an aseptic cleanroom environment.

Here are Cleanroom Connection’s top-selling USP 800 compliant cleanroom PPE:

True Care BioMedix Sterile Chemo Gowns

True Care Biomedix TCBA54ST sterile chemo gowns are the company’s most popular USP 800 compliant gown. These gowns are clean-processed for use in ISO5 Class 100 environments and gamma-sterilised making them safe for use in sterile areas. Available in sizes small through 3X-large to ensure the most critical environment workers will find a good fit. These gowns meet the USP 800 requires that all personal protection equipment (PPE) be tested for chemotherapy permeation using American Society for Testing and Materials (ASTM) D6978-05 standards.

BioClean sterile chemotherapy preparation mats

BioClean’s S-BCPM sterile chemo prep mats are a brand new item specially made for USP 800 compliance. These sterile prep mats have been clean-processed to an ISO5 Class 100 level. They are safe for use in your pharmacy hood. For maximum sterility compliance, each mat is individually wrapped and sterile. Choose from 16in x 10in or a larger 16in x 22in size.

Bioclean sterile chemo mats are made of three layers with an impervious backing to ensure no liquids soak through.

CT International NSGF sterile nitrile chemo gloves

When working inside a USP 800-compliant cleanroom or hood, you cannot use the standard purple or blue nitrile gloves. These non-compliant medical grade gloves will introduce particles and contamination into your environment.

CTI sterile nitrile NSGF series gloves are ISO5 Class 100 compliant and are tested by ASTM D6978-05 standard for USP 800 compliance.

Choose from sizes six to ten, including half sizes for the perfect fit. USP 800 compliance requires double-gloving. Most cleanroom workers use a half-size larger for the outer glove.

WipeDown 1-2-3 chemotherapy cleanup wipe kit

Instead of the inconvenience and even non-compliance from having to use multiple chemicals and wipes for deactivating, decontaminating, and disinfecting spilled chemotherapy, use Cleanroom Connection’s WipeDown 1-2-3 kit.

The Wipedown 1-2-3 chemotherapy cleanup kit is one of the easiest and most convenient ways to deactivate and clean-up chemo drugs. This three-step kit is made in the US and widely used by hospitals and pharmacies.

The Step One wipe contains 5.25% sterile sodium hypochlorite; Step Two, sterile 2% sodium thiosulfate; and Step Three, sterile 70% isopropyl alcohol. The wipes are 9in x 12in.

USP 800 compliance consulting and guidance

Cleanroom Connection has been at the centre of educating customers on USP 800 compliance for the past two years. The company help our pharmacy and hospital lab customers be confident in their compliance and save money while receiving great customer service from their assigned account manager.

If you are looking for guidance on choosing the proper cleanroom apparel or cleaning supplies for compliance in your aseptic cleanroom, please contact Cleanroom Connection for help. Consulting on-site and off-site are available through its team of veteran compounding pharmacist consultants with more than 30 years of compliance experience.

Visit Cleanroom Connections’ website at or use the contact form on this page.

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