P: 888-222-2956
F: 866-373-2979
P: 888-222-2956
F: 866-373-2979
For this months edition, we decided to focus on clean-room procedures and techniques. All sterile injectable products are made in our clean-room environment, in accordance with state and federal guidelines. This ensures your patients receive a high quality, pure product every time. MedQuests clean-room was developed to prevent microbial contamination, bacterial endotoxins, or chemical and physical contamination. It also ensures that variances in strengths, or ingredients of inappropriate quality, do not get into compounded sterile preparations (CSPs).
The following topics will discuss the layout of our compounding facility, an overview of the critical standards needing to be met in the clean-room, and what it takes to make a clean-room an effective workflow environment to produce the highest quality product.
Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. These facilities provide a comfortable and well-lit work environment, which includes a temperature that maintains comfortable conditions for compounding personnel to perform flawlessly when attired in the required aseptic compounding garb.
The three distinct work areas (secondary-ante area, primary ante-area, and buffer area) minimize airborne contamination from contacting critical sites and ensure that each area meets ISO (International Organization for Standardization) classified air environments. The secondary ante-area is where hand hygiene/garbing procedures and order entry are performed to provide a clean bulk storage area. The primary ante-area is a final staging area where bulk ingredients, compounding equipment, and personnel can be sterilized before entering the buffer area. The buffer area houses the primary engineering control (PEC), a vertical laminar airflow workbench in the buffer area that serves as a work area. Bulk non-sterile medications are filtered and sterilized and CSPs are packaged according to orders in this area. The buffer area also provides a work area to produce non-sterile medications, prepare components and supplies for CSPs, and label CSPs.
In order to meet certain ISO ratings within our clean-room, certain tests must be conducted according to the required schedule set forth in United States Pharmacopeia (USP). Environmental testing regulates that the PEC is maintaining an environment within the compounding area that consistently ensures acceptably low and nonviable particle levels.
At MedQuest, testing is conducted every month and results are recorded electronically, to stay abreast of cleaning policies and procedures for the clean-room facility. Once all viable and nonviable testing is complete, a report is sent to the pharmacy by the testing company outlining the results for PEC testing, ISO Class ratings, and air pressure differential readings for the clean-room facility.
Certification of facility, equipment, and staff is essential in reducing contaminants. Sources of potential contamination include, but are not limited to the following:
The MedQuest clean-room has developed a consistent workflow that allows for maximum productivity, while keeping patient and product safety as the highest priority.
Clean-Room Prep: The work begins as the clean-room personnel assess the daily workload and print necessary labels for all compounded sterile preparations (CSPs) to be made that day. Then, each ingredient is calculated. These calculations are recorded and logged to be double checked by both a pharmacy technician and a pharmacist.
Dressing/Attire: After the information is logged, clean-room personnel remove personal outer garments (e.g., bandannas, coats, hats, jackets, scarves, sweaters, vests); all cosmetics, because they shed flakes and particles; and all hand, wrist, and other visible jewelry or piercings (e.g., earrings, lip or eyebrow piercings,) that can interfere with the effectiveness of personal protective equipment (PPE). The wearing of artificial nails or extenders is also prohibited while working in the sterile compounding environment. Natural nails shall be kept neat and trimmed. Garbing takes place by covering shoes, using head/facial hair covers (e.g., beard covers in addition to face masks), and face masks/eye shields. Eye shields are optional unless working with irritants such as germicidal disinfecting agents, or when preparing hazardous drugs.
Hand Cleansing Procedure: After covers are put on, a hand cleansing procedure needs to be performed by removing debris from underneath fingernails using a nail cleaner under running warm water, followed by vigorous hand washing. Hands and forearms need to be washed to the elbows for at least 30 seconds with soap (either non-antimicrobial or antimicrobial) and water while in the ante-area. The use of antimicrobial scrub brushes is not recommended, because they can cause skin irritation and skin damage. Hands and forearms to the elbows will be completely dried using either lint-free disposable towels or an electronic hand dryer.
Clean-Room Apparel: After completion of hand washing, a non-shedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned. Gowns for buffer area use need to be worn, and preferably they should be disposable. Once inside the buffer area and prior to donning sterile powder-free gloves, antiseptic hand cleansing shall be performed using a waterless alcohol-based surgical hand scrub. Hands are allowed to dry thoroughly before donning sterile gloves. Sterile gloves are the last item donned before compounding begins. Gloves become contaminated when they contact nonsterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing 70% isopropyl alcohol, or a 2% bleach solution, to all contact surface areas of the gloves and letting the gloved hands dry thoroughly.
Sterilize & CSPs Procedures: Once appropriately garbed, clean-room personnel will sterilize the primary engineering control (PEC) with a 2% bleach solution and allow it to dry. All vials and equipment are then sterilized with 2% bleach and vials are labeled with product labels and arranged in order to be filled. After empty product vials are sterilized, labeled and arranged, clean room staff begins preparing all CSPs for the day ensuring that the PEC is cleared off and sterilized whenever there is a change in batch medications, every thirty minutes during continuous compounding periods, and when there are spills or other surface contaminations. A pharmacist will check each medication batch when it is complete, verifying product calculations, usage of correct medications, and accuracy of CSPs labeling. After all CSPs are made and sterilized, clean room personnel will complete the daily cleaning schedule. This includes wiping down all work surfaces, sterilizing footwear, and mopping floors using a 2% bleach solution.
We hope you find this information useful in assuring your patients that they will always receive the very best quality products prepared in the most sterile environment. If you are ever in Salt Lake City, UT and would like to tour our facility we would welcome the opportunity.
McFadden R. (2011 July 26). A Basic Introduction to Clean Rooms. Coastwide Laboratories: 8.
United States Pharmacopeial Convention, Inc. The National Formulary. Chapter 797, USP 797 Pharmaceutical Compounding Sterile Preparations et seq. 2011.
