Usp 800 Report

ASEPTIC ENCLOSURES AWARDED PRIMARY ENGINEERING CONTROL DEVICES AGREEMENT WITH PREMIER, INC.

Aseptic Enclosures has been awarded a group purchasing agreement for Primary Engineering Control Devices (I.V. Hoods) with Premier, Inc., a leading healthcare improvement company. Effective July 1st, 2016, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier.
Aseptic Enclosures Primary Engineering Control Devices (I.V. Hoods) contract offers a wide range of custom equipment to meet USP 797 and USP 800 compliance, from compounding aseptic isolators to hoods and clean benches. Our first priority is to help your facility create the most aseptic and safest working environment possible. Having as broad of a product line as we do, provides us the opportunity to look at solutions from multiple potential platforms to secondarily help create an environment that is ergonomic, functional, efficient and cost-effective.

About Premier, Inc.

Premier is a leading healthcare improvement company uniting an alliance of approximately 3,600 hospitals and health systems and 120,000 other providers. Please visit Premier’s website at www.premierinc.com for more information about the company.

About Aseptic Enclosures

Parenteral production has been on of our company’s focal points since its founding in 1992. First, in cGMP compliant FDA registered pharmaceutical manufacturing facilities, and now, since 2005, the “end user” Pharmacy Sterile Compounding segment.
Aseptic Enclosures first entered into the hospital pharmacy market with the introduction of our CAI “compounding aseptic isolators” and CACI “compounding aseptic containment isolators”. Since that time our product line has grown to be the most comprehensive range of solutions for USP 797 and USP 800 compliance. Please contact us at 1-800-418-9289 and let us know how we can help!

USP 800 Chapter

USP Publishes Standard on Handling Hazardous Drugs in Healthcare Settings

Rockville, Md., February 1, 2016—The United States Pharmacopeial Convention (USP) published today an important new standard as part of a suite of healthcare quality standards included in the United States Pharmacopeia-National Formulary (USP-NF).

The new general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings, has been developed to help protect personnel and patients, and reduce the risk of residual exposure in healthcare settings. The standard applies to all healthcare personnel (i.e., physicians, nurses, veterinarians, pharmacists and technicians) and all healthcare facilities where hazardous drugs are handled or manipulated, including their storage and distribution— with a goal of preventing and/or limiting exposure.

“Healthcare workers are on the frontline of protecting patients and consumers from the risks of hazardous drugs but are also themselves at risk,” noted Jaap Venema, Ph.D., executive vice-president and chief science officer of USP. “Each year, approximately 8 million healthcare workers in the US are potentially exposed to hazardous drugs. Practitioners are frequently unaware of the scope of the risk or the measures that should be taken to reduce such risk. The new standard defines processes intended to minimize exposure to hazardous drugs in healthcare settings, thereby protecting healthcare workers as well as patients.”

The standard was developed by the USP Compounding Expert Committee with input from an expert panel of medical and industry experts who provided guidance in best practices, alternative techniques, engineering controls, and other elements needed when handling hazardous drugs in healthcare settings. The standard builds upon several previous publications, including the NIOSH Alert-Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings; OSHA Guidelines; ASHP Guidelines on Handling Hazardous Drugs; and the Oncology Nursing Society (ONS) Safe Handling of Hazardous Drugs.
The USP Compounding Expert Committee recognized that it may take healthcare facilities additional time to comply with the new standard and therefore approved an extended official implementation date of July 1, 2018. With the extended date, healthcare facilities have more than two years to conform to the new requirements.

Read new USP 800 Chapter here, USP Release-800-publication

 

 

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