Providing Cleanroom Certification, ASHRAE 110 Testing, Calibration, Decontamination, USP 797 Solutions, Compressed Air Line Testing, Environmental Monitoring and Qualification Services

USP 797 INDEX

Preparations:

Are you prepared?

USP 797 Training

Solutions:

Micro-Clean has solutions for your Environmental Control and Testing Needs.

USP 797 Compliance
Solutions

On-Site USP 797
Gap Analysis Request

Opinions:

Micro-Clean's Position
on US 797

Sterile Preparations Documents:

USP 797 Pharmaceutical Compounding – Sterile Preparations

Update of USP 797 Document

JCAHO Timeline

USP 797 Compliance
Resources

Supplies & Equipment:

USP 797 Supplies & Equipment

USP <797> PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS SOLUTIONS

Do you know where to turn to for your USP <797> compliance solutions?

The answer is right HERE (Micro-Clean, Inc. On-Site USP 797 Gap Anaysis Request).

Micro-Clean, Inc. has teamed up with Clinical IQ, LLC and Controlled Environment Consulting, Inc. to provide our pharmaceutical customers with a single-source for their USP <797> compliance solutions.

The solutions consist of a comprehensive on-site USP 797 Gap Analysis to determine areas requiring attention and a report describing corrective actions as well as positive feedback on all USP <797> compliance issues such as:

• Responsibilities of all compounding personnel
• Basis for the classification of a CSP (Compounding Sterile Preparations) into low-, medium-, or high-risk level, with examples of CSPs and their quality assurance practices in each of these risk levels
• Verification of compounding accuracy and sterilization
• Personnel training and evaluation in aseptic manipulation skills, including representative sterile microbial culture medium transfer and fill challenges
• Environmental quality and control during the processing of Compounding Sterile Preparations
• Equipment used in the preparation of Compounding Sterile Preparations
• Verification of automated compounding devices for parenteral nutrition compounding
• Finished preparation release checks and tests
• Storage and beyond-use dating
• Maintaining product quality and control after CSPs leave the compounding facility, including education and training of personnel
• Packing, handling, storage, and transport of Compounding Sterile Preparations
• Patient or caregiver training
• Patient monitoring and adverse events reporting
• A quality assurance program for Compounding Sterile Preparations

This team is lead by:

Eric S. Kastango, RPh, MBA, FASHP, President, Clinical IQ, LLC
James T. Wagner, President, Controlled Environment Consulting, Inc.

Eric Kastango has been in the forefront of USP <797> since its inception. He is an elected member of the United States Pharmacopoeia Sterile Compounding Committee (2005-2010). Over the years, he has held multiple American Society of Health-System Pharmacists chairmanships and committee positions. He was responsible for creating the “Comprehensive Sterile Compounding Compliance Gap Analysis and Risk Assessment Tool” being used and marketed by the ASHP.

Jim Wagner has been an industry leader in the field of HEPA filtration and environmental control for over 25 years. He is an elected member of the United States Pharmacopoeia Engineering Controls Committee (2005-2010). He is the current president of the Controlled Environment Testing Association , an industry organization currently developing recommended practices for aseptic compounding facilities, an isolator applications guide and compounding isolator testing.

Request a quotation by clicking right HERE ( Micro-Clean,Inc. USP 797 Comprehensive On-site Gap Analysis Request)

Micro-Clean, Inc. also hosts Pharmacist Training in our Lehigh Valley facility:

The Aseptic Training Program offered by Clinical IQ, LLC and Controlled Environment Consulting in cooperation with the Contamination Control Institute (C2I) will offer participants the unique opportunity to combine classroom training and hands-on practice to develop and enhance their sterile compounding skills, while learning how to integrate quality into their daily activities. Attendees will have the opportunity to work in a cleanroom, barrier isolators, biological safety cabinets and laminar airflow workbenches and will undergo aseptic media fill qualification, learn how to establish an environmental monitoring program, perform environmental sampling, cleaning and sanitizing, designing and building a cleanroom.

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