USP 800 has been proposed and it currently undergoing finalization to be released in the near future.
[UPDATE: Since this article first appeared, USP 800 is finalized. See our USP 800 compliant products page which includes a free downloadable USP 800 compliance checklist and other valuable information.]
USP 800 has a goal of maximizing safety for pharmacy and healthcare workers who handle hazardous drugs like chemotherapy. When manufacturing hazardous drugs in a compounding pharmacy, there are many opportunities for skin contact. To minimize risk of workers being contaminated by contact, new personal protective equipment guidelines have been laid out to improve the safety measures that are to be taken in all settings where hazardous drugs are handles, including compounding pharmacies, oncology pharmacies, hospitals and other medical facilities.
How We Can Help With USP 800 Compliance
Cleanroom Connection not only provides a complete selection of appropriate chemo gowns, chemo gloves, and other protective apparel, but our cleanroom-experienced staff have completed USP 800 training to ensure our customers benefit from working with a cleanroom supplier that fully understands compliance. USP Chapter 800 – Section 6, deals with the required personal protective equipment for all people handling hazardous drugs. These gowning guidelines offer the front line of defense for healthcare workers. Below are brief explanations of each section of USP 800 Section 6 and briefly touch upon and explain each gowning category for compliance.
USP 800 Gowning Guidelines
The USP recommends polyethylene-coated polypropylene gowning and other protective apparel that are impervious for maximum protection.
“These materials are far less breathable and comfortable to wear than lesser protective apparel workers are used to wearing. The behaviors of the employees must be changed and compliance with appropriate garbing enforced in order to ensure effectiveness. This is often the largest hurdle that one will face. The compounding environment must have a controlled temperature and humidity to encourage the personnel to wear these less breathable materials that will make up Personal Protective Equipment. If the temperature and/or humidity is too high and the employee sweats through the material it decreases the protective nature of the PPE as well as discouraging appropriate gowning behaviors.” states Kenneth Latta, BS, RPh, FIACP, FACA and a Senior Associate at Gates Healthcare Associates. In the next section we will touch upon each PPE section as outlined in the proposed USP Chapter <800>.
USP 800 – Section 6.1 Gloves
Section 6.1 of USP 800 deals with the appropriate gloves that should be worn by workers handling HDs. It states that the correct gloves will be ASTM tested and approved with either labeling on the box stating this or with test results available from the glove manufacturer. It also states that the correct gloves will be be powder free, inspected and are to be double gloved for maximum protection.
USP 800 – Section 6.2 Gowns
Section 6.2 of USP 800 explains that polyethylene-coated polypropylene gowns are to be used since they are impervious. They are to be single-use, disposable and tested to resist any permeability. USP 800 compliant gowning is to have long sleeves, a closed-back, snug fitting elastic cuffs, and have no loose seams or closures. For aseptic compounding and environments, sterile chemo gowns may be more appropriate, and are available from Cleanroom Connection.
USP 800 – Section 6.3 Head, Hair, Shoe, and Sleeve Covers
Section 6.3 of USP 800 discusses bouffants, shoe covers and sleeve covers that are to be used for compliance. Similar to the gowning materials recommended, these hair covering should also be impervious and made from a coated, non-shedding material, preferable polyethylene-coated polypropylene. Test results for permeation should be available, preferably having been tested with hazardous drugs like chemotherapy.
USP 800 – Section 6.4 Eye and Face Protection
Section 6.4 of USP 800 discussed eye protection. It discusses goggles and full-face respirators as proper facial and eye protection methods. It states that glasses with side-protectors or face shields alone are not adequate, and should be used in conjunction with goggles. Full faceplate respirators, goggles, face shields and safety glasses are available from Cleanroom Connection.
USP 800 – Section 6.5 Respiratory Protection
Section 6.5 of USP 800 deals with ensuring respiratory protection when handling hazardous drugs. NIOSH-certified N95 masks are mentioned as sufficient protection against airborne particles, but not adequate for protecting against gas and vapors. Cleanroom Connection stocks a special activated-charcoal NIOSH-certified R95 mask that provides adequate protection for exposure to noxious amounts of vapor.
USP 800-Trained Cleanroom Supplier
Cleanroom Connection staff actively study all relevant USP chapters, regularly complete rigorous product training, and have a vast network of pharmaceutical compounding pioneers on its team. They offer a unique and complete solution for newly built or long-established compounding pharmacies, hospital labs, and other healthcare facilities that seek USP 800 compliance.
On-site consultation, staff training, mock-audits and complete implementation of USP 800 is available through Cleanroom Connection.