Leading the Way in Contamination Control Products for use in Critical Compounding Environments
See how Contec Healthcare’s solutions meet and exceed USP standards
Overview
Critical Cleaning Zones
Contec + USP Chapters
The United States Pharmacopeia (USP) is a scientific nonprofit organization that sets standards for strength, quality and purity of medicines.
USP General Chapters are set in place to provide minimum practice standards for healthcare facilities overseeing compounding activities.
Overview
The United States Pharmacopeia (USP)
These standards are to be used by practitioners to help ensure the quality of compounded procedures and preparations.
As a world-class manufacturer of EPA-registered products and with over 100 combined years of experience in supporting critical environments, Contec Healthcare is committed to meet specific needs of compounding operations and pledge to continue to adapt as science and demands in the field evolve.
The updated protocols in Chapter <797> contain minimum standards required for pharmacy sterile compounding practice and will become official on November 1, 2023.
USP Chapter <797>
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Contec Healthcare provides products for cleaning and disinfection and related work practices for sterile compounding.
Our wipes come in multiple configurations and meet and exceed all requirements to comply with USP standards.
Wipes
With over 100 combined years of experience in supporting critical environments, we are committed to product research to ensure our products do what they say, and are responsive to customer demands. Browse our solutions below:
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Contec Healthcare’s selection of cleanroom apparel provides the optimal balance of protection, compliance, durability, and comfort.
Garb
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Our solutions include cleaning and disinfecting agents you need to achieve and maintain a microbial state-of control.
Disinfectants and Chemicals
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Our low-lint mopping systems and accessories, meet and exceed USP standards associated with cleaning and disinfecting PECs and SECs.
Mops
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Understand Critical Cleaning Zones
Learn about critical cleaning zones in compounding pharmacies and considerations that will help pharmacists maintain a state of control.
Critical Cleaning Zones
In nonhazardous sterile compounding, the buffer room has positive pressure and maintains at least ISO 7 air under dynamic operating conditions. It must have fixed walls and doors and is the room where PECs are located. The buffer room may be accessed only through the anteroom or another buffer room.
Buffer Room
A Laminar Airflow Workbench (LAFW) is a type of Primary Engineering Control (PEC) that is a positive pressure device providing an ISO 5 environment for sterile nonhazardous compounding. These devices should be equipped with casters since they must be moved during daily and monthly cleaning. Alternatively, a Restricted-Access Barrier System (RABS) can be used here such as a Compounding Aseptic Isolator (CAI).
PEC
(Primary Engineering Control)
The DCA is where critical sites are exposed to unidirectional HEPA-filtered air (first air). Uninterrupted first air must bathe the critical site throughout compounding.
DCA
Things to consider include:
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The table used by the compounder to stage components going in and out of the PEC should be wiped with sterile IPA (sIPA) before and after each batch or patient prep to reduce the risk of introducing contamination into the PEC.
Provide a work table for donning sterile gloves. Include a place for closed sterile glove storage, alcohol-based hand sanitizer, and sterile spray IPA nearby.
Best practice placement of a pass-through from non-ISO classified prep area to buffer room will minimize the traffic through the anteroom reducing the potential for the introduction of contamination and vastly improve efficiency of workflow and CSP staging.
The anteroom is primarily a place for personnel hand hygiene and garbing which generates high particulate levels and is a transition between the unclassified area and the ISO 7 buffer room. An anteroom serving only a nonhazardous buffer room must maintain positive pressure and at least ISO 8 air under dynamic operating conditions.
Best Practice Elements:
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Visible Line of Demarcation (LOD) that separates the clean and dirty side of the anteroom.
Bench or stool for donning shoe covers straddling the LOD.
Storage for head, face, and beard covers as well as shoe covers.
Wall-mounted mirror (sealed with caulk around perimeter) to use to check that head cover donned properly.
Soap container (not to be topped off or refilled).
Low-lint wipe dispenser to dry hands.
Clock with second hand so staff can time 30 second hand/arm lathering.
Low wall air returns, usually more than 1 in each room, but placement of one near sink is desirable since potable water contains many microbes.
Gowns and garb stored in a manner that minimizes contamination (closed storage) and away from sinks.
Anteroom
Click on the USP Chapters below to understand how Contec products and best practices can help you stay compliant
Contec Healthcare + USP Chapters
Hazardous Drugs — Handling in Healthcare Settings specifically addresses the handling of compounded Hazardous Drugs (HDs*) in healthcare settings.
USP Chapter <800>
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USP <800> is intended “to protect personnel and the environment when handling HDs. Understanding the definitions, best practices, and recommended solutions are key to meeting the USP <800> standards.
USP Chapter <825> is intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and...
USP Chapter <825>
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USP Chapter <825> is intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities (e.g., the practice of pharmacy and the practice of medicine).
Our technical experts are great resources who can review facility protocols and help determine the best products to meet your needs.
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NEXT: USP CHAPTER 797
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Contec Healthcare offers high-quality USP compliant cleanroom supplies that you can rely on.
Cleanroom Supplies
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DCA (Direct Compounding Area)
PEC (Primary Engineering Control)
Buffer Room
Anteroom
DCA (Direct Compounding Area)
PEC (Primary Engineering Control)
Buffer Room
Anteroom
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The updated protocols in Chapter <797> contain minimum standards required for pharmacy sterile compounding practice and will become official on November 1, 2023.
USP Chapter <797>
LEARN MORE
USP Chapter <800>
Hazardous Drugs — Handling in Healthcare Settings specifically addresses the handling of compounded Hazardous Drugs (HDs*) in healthcare settings.
USP Chapter <825>
LEARN MORE
