Mandatory Steps for Effective Cleanroom Design

 

Many manufacturing processes need the very stringent environmental conditions that can only be provided by a cleanroom.

VA Publishes their Pharmacy Design Guide

Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these facilities are governed by the Veteran Administration.

Don’t Stop Production for Cleanroom Renovation

 

Sterility Assurance of Hospital Pharmacy Compounded products

Compounding medications is essential to patient care. All types of medications can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion.

USP 800 Checklist: Priority Areas to Address

To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.

 

Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting.

Three things to consider when upgrading to meet USP 800

Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.

The Risks of Automated Compounding of IV Products

The last couple of years we have recorded a serious upswing and increase of use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of such technology we’ve seen an increase in the risks and sources of contamination of compounded products when prepared with an IV automation workflow machine. Currently there are many TPN compounder manufacturers on the market, such as Epic, Baxter, Baxa, MedKeeper, Omnicell, ICU medical and many other players in this segment. We’ve been carefully monitoring the responses regarding these types of machinery whenever there was an inspection by the FDA at a facility that houses and uses such technology. Pretty much all oversights noticed issues with the proper placement of the IV compounder in the working area; issues that either exposed the operator to risks or cases where the technician contaminated the product.

Reducing Risks of Exposure to HDs

Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving.

What is USP <800>?

 

Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed.  The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” This same organization also sets standards for general pharmacy practice.

Percentage of USP 797 & USP 800 Compliance