ON-SITE EVALUATION OF YOUR FACILITY
When it comes to cleanroom design, fabrication, installation, pricing, and customer service, we do clean rooms right. The importance of understanding your current situation is always a great starting point for any type of project. So our pharmacy project engineers are now conducting on-site visits for inspection and evaluation of your cleanroom areas in your facility.
Primary Engineering Control Devices for Premier, Inc. GPO
What Are Universal Precautions?
Customizing Industrial-Quality Workbenches for Your Needs
Workbenches are used in many industries including those engaged in manufacturing, assembly, packaging, and shipping. Industrial-quality workbenches are also found in laboratories, educational institutions, research centers, and healthcare facilities. Whether they are subjected to light, medium, or heavy use, these furnishings may become more functional when certain accessories are added. Some accessories are designed for specific environments and others are useful in all industries.
Developing a Robust Compounding Strategy
Revised 503B Guidance for Outsourcing Compounders
According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.
Updated Regulation for Compounding Aseptic Isolators
1. Biological Hazards
Contact with patients and the public exposes pharmacy staff to biological hazards, as will contaminants found in food, water, and the ventilation system. The immunization of workers provides a first line of defense when interacting with patients.
Other measures should also be put into place, including the restriction of access to authorized personnel only, implementation of safe work procedures, and use of personal protective equipment, such as eye protection, gloves, and respiratory protection.
Care should not only be exercised on the medication contained within a pharmacy; the building itself should also be given attention, particularly the ventilation system. Regular maintenance reduces the risk of contamination.
Trends in USP <800> Compliance
With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting some 800-compliant practices; for example, most facilities already segregate their HD inventory from non-HDs in storage. However, other recommended practices are far from widespread; for example, few hospital pharmacies conduct HD spill simulations and wipe analyses on a regular basis. As such, many facilities do not have a firm understanding of the impact of HD contamination in their facility, nor can they be assured that their staff will respond properly when an HD spill inevitably occurs.
Can an Isolator still be used without a Cleanroom
The answer is complicated.
Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.