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USP 800 Compliance For Hazardous Drug Compounding

Everything You Need For USP 800 Compliance From One Source

how to get ready for usp 800 compliance

USP 800 Hazardous Drugs – Handling in Healthcare Settings updates the current USP 797 sterile preparations regulations regarding the handling of hazardous drugs in compounding pharmacies, hospital pharmacies, and medical centers. These new regulations and guidelines offer more protection to pharmacists and lab workers to ensure safe handling of chemotherapy and other hazardous drugs. USP 800 compliance, as well as USP 797 compliance, is our specialty here at Cleanroom Connection. We work with industry leaders in the pharmaceutical compounding world to make sure we are carrying the best cleanroom supplies and personal protective equipment. We are partners with the nation’s leading USP 800 pharmacist consultants, cleanroom designers, staff-trainers, and organizations. We offer complete turnkey USP 800 compliance programs for hospitals, pharmaceutical manufacturers and independent sterile compounding pharmacies.

Is Your Pharmacy/Lab in USP 800 Compliance?

free download of a usp 800 compliance checklistCall to speak with one of our cleanroom consultants about bringing your compounding pharmacy or hospital laboratory into compliance. Or download and complete this USP 800 checklist

Scroll down to view our most requested USP 800 cleanroom cleaning supplies and compliant apparel for handling chemotherapy and other hazardous drugs. We also offer USP 800 compliance services for hospitals, pharmacies, and drug manufacturers.

Sterile Chemo Gowns

image representing impervious chemo gowns for usp 800 compliance

Impervious chemo gowns are ASTM chemo tested and approved for use in USP 800 compliant facilities. Polyethylene coated polypropylene gowns and coats for safe handling of chemo. Chemo apparel available from BioClean, TrueCare and Covidien. Our USP 800 compliant sterile chemo gowns have a closed front, are breathable, have a closed back with velcro & ties, and are ISO5 Class 100 compatible.  They are individually wrapped and some in sizes Small – 3XL.

Chemo & HD Gloves

chemobloc gloves

Chemo gloves and sterile chemo-safe cleanroom gloves in latex and latex-free nitrile material. Multiple thicknesses. USP 800 requires ASTM chemo-rated gloves be used when handling hazardous drugs. Our chemo gloves all come with ASTM test results and are available both sterile and non-sterile. Our USP 800 chemo gloves are made by BioClean, Kimbery Clark, CTI, Covidien, Ansell and other high quality manufacturers.

Sterile Chemo Mats

image representing sterile chemo prep mats

Sterile chemotherapy preparation mats are individually packaged, sterile, ISO5 compliant and come in two convenient sizes. These sterile chemo mats are made of 3 layers and impervious. They will absorb and protect workers from small spills as well as keep surfaces dry. Choose from 16″x10″ or 16″x22″  sizes on our sterile USP 800 compliant lint-free chemo mats. They are ISO5 Class 100 certified and the highest quality on the market.

 

Sterile Chemo Goggles

sterile cleanroom goggles

High-quality cleanroom goggles and sterile-single use goggles will protect your eyes from hazardous drugs. These goggles are to be used in conjunction with the appropriate face mask. Choose from autoclavable or single-use disposable goggles. Our sterile chemo-protection goggles come in both sterile single-use and sterile autoclavable reusable versions. They are also ISO5 Class 100 certified and compatible.

WipeDown 123 Kit

image representing sterile wipedown 1-2-3 wipe kit from veltek for chemo and hazardous drug cleaning and deactivation

Our Wipedown 1-2-3 chemotherapy cleanup kit is the easiest and most convenient way to deactivate and clean-up chemo drugs. This 3 step kit is is made in the USA and widely used by hospitals and pharmacies. Step one wipe contains 5.25% sterile sodium hypochlorite, step two wipe contains sterile 2% sodium thiosulfate and the step 3 wipe contains sterile 70% isopropyl alcohol. The wipes are 9″x12″.

Sterile Chemo Sleeves

image representing sterile chemo sleeves for protection against chemotherapy

Sterile chemotherapy sleeves offer adequate protection for your arms, whether these sleeves are used over existing sleeves or to bridge a gap between your wrist and your gown cuff. Impervious sleeves offer protection to your arm when handling HDs. Our sterile chemo sleeve protectors have taped seams to ensure no liquid can permeate. These sterile sleeve protectors are individually wrapped and ISO5 Class 100 compatible.

Chemo Handling

image representing chemo spill kit products from covidien

Chemo products include our complete offering of protective apparel, spill kits, gowns, gloves, IVA seals, prep mats and more. USP 800 compliance is easy with our guidance and selection of personal protective equipment. We sell chemotherapy spill kits in a variety of configurations as well as everything else you need to wear and handle chemotherapy safely and maintain USP 800 compliance. Contact us with all your USP 800 questions.

Cleaning Chemicals

image representing hypo-chlor sterile sodium hypochlorite cleanroom bleach

Our USP 800 cleanroom cleaning chemicals are also used to clean and deactivate chemotherapy. These cleanroom-grade chemicals include Hypo-Chlor sterile 5.25% sodium hypochlorite as well as Cidehol 70 ST and Decon-Ahol sterile 70% cleanroom-grade isopropyl alcohol. Use our sterile dry wipes along with these chemicals to ensure your clean room is always clean. Contact us for guidance on deactivating chemotherapy and how to clean-up.

USP 800 Consulting

image representing usp 800 compliance consulting and training

USP 800 compliance consulting and training services are offered by Cleanroom Connection. Our team of veteran pharmacist consultants are pioneers in the compounding and pharmacy management industry. Get on-site guidance, cleaning training, troubleshooting and customized standard operating procedure creation for your hospital or pharmacy. USP 797, USP 800 and cGMP consulting services are available throughout the USA, Canada and Australia.

WE OFFER EXPERT LEVEL USP 800 CONSULTING SERVICES

 

 

SOME NEW RULES WITH USP 800

 

Separation of Hazardous Drugs

Another change is that compounding and other manipulation of hazardous drugs must be performed in a containment primary engineering control (C-PEC) within a separate room. The goal is additional personnel protection. The C-PEC’s room must be under negative pressure, externally vented, and have the appropriate number of air changes per hour.

Co-Mingling of Non-Antineoplastic Hazardous Drugs

USP 800 allows for non-antineoplastic hazardous drugs that are available in final-manufactured dosage forms and on the NIOSH list may be co-mingled with non-hazardous drugs stock if the pharmacy policy allows. Note that an additional stipulation is that the permitted co-mingled drug must not be manipulated other than counting for dispensing.

On-Site Training and USP 800 Implementation

Cleanroom Connection offers the below on-site services to help your facility implement USP 800 compliance whether you are a an independent compounding pharmacy, hospital compounding pharmacy, oncology pharmacy, pharmaceutical manufacturer or healthcare facility.

We offer a wealth of resources to ensure USP 800 compliance in your hospital, compounding pharmacy, or medical center. Our training partners offer a comprehensive training program and demonstrations on gowning, cleaning, and creation of standard operating procedures (SOP) for compliance with USP Chapter 800.

Our cleanroom consultants can help you with USP 800 implementation. From answering your questions about protocols to helping you order chemo-rated apparel, gloves, wipes, masks and other cleanroom apparel that’s made for use in the handling of hazardous drugs. We also offer a complete selection of lint free and sterile cleanroom apparel and disinfectants to ensure a contamination free environment. Cleanroom Connection offers a complete solution for compliance with USP including the proper protective apparel, cleanroom cleaning supplies, on-site training, SOP creation, and guidance to ensure complete understanding and compliance. We specialize in working with hospital pharmacies and helping them implement USP 800 protocol.

Let Us Help You With USP 800 Compliance

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