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.
USP 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
Featured Products:
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
Best Practice Elements:
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Have a staging table available for operators to stage components as they go in and out of the PEC to improve efficiency of workflow and CSP staging.
Locate a worktable in the buffer room (or other location where sterile gloves are donned) for donning gloves on which can be placed alcohol-based hand rub and sterile IPA.
Walk and move slowly while in the buffer room (especially nearby the PEC) to minimize particulate generation.
Consider prohibiting music in the buffer room to
increase worker concentration. Music volume is often turned up high to overcome the sound of the HVAC resulting in a noise decibel level that requires workers to raise their voices to be heard. Raised voices not only increases particle generation but background noise of that levels can cause long term hearing loss.
Provide stools that are height adjustable, have a back support, and do not have wheels. Eliminating wheels from stools saves valuable cleaning time and reduces potential bioburden.
Featured Products:
Best Practice Elements:
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•
•
•
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Clean and disinfect the sink every day. Scrub the visible portion of the drain and discard any strainer if present.
Fill the drain at the end of cleaning with an EPA-registered sporicidal disinfectant cleaner (like PeridoxRTU®) and allow it to dwell on a weekly or monthly basis.
Use a low-lint wipe dispenser to dispense wipes for hand drying. These devices should be such that 1 or 2 wipes are easy to dispense, and the pack of wipes is encased in plastic and closed to prevent contamination and reduce particulates.
Mount a clock with a second hand over the sink so that staff can easily time the lathering time of 30 seconds. This clock is best hung on the wall and removed at least monthly to clean and disinfect the clock and wall surfaces beneath with an EPA-registered sporicidal disinfectant cleaner.
Place a wall-mounted mirror (sealed with caulk around the perimeter of the mirror) where head covers are donned to facilitate verification of proper placement.
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
Explore Our Products and Solutions
Contec Healthcare offers high-quality USP compliant cleanroom supplies that you can rely on.
Cleanroom Supplies
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DCA (Direct Compounding Area) and the Interior of the Primary Engineering Control (PEC)
Exterior Surfaces of the Primary Engineering Control (PEC)
Buffer Room
Anteroom
DCA (Direct Compounding Area) and the Interior of the Primary Engineering Control (PEC)
Exterior Surfaces of the Primary Engineering Control (PEC)
Buffer Room
Anteroom
Contec Healthcare
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Click on the tabs to explore the cleanroom
Contec Healthcare
Explore Our Products and Solutions
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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
Featured Products:
Best Practice Elements:
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•
•
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•
Install casters on PECs to facilitate daily movement for floor cleaning.
PECs need to be moved at least monthly so that the exterior surface and the wall behind it can be cleaned.
Get magnetic hooks and place one on the back of each PEC to hold the power cord off the floor.
In addition to cleaning the pass-through chamber, work surfaces, and floor outside the PEC daily as required by USP <797>, also include high-touch areas (e.g., door handles, the exterior of spray and pump bottles, etc.) with PREempt® Plus or Contec® Healthcare TB1-3300™ One-Step Disinfectant Cleaner. During monthly cleaning of all room surfaces and furniture, use PeridoxRTU®.
Prefilters in all PECs should be checked monthly. Prefilters in PECs in buffer rooms are likely to require changing only by your certifier but prefilters in PECs in SCAs may require changing/cleaning every 1-3 months since the air in that space is dirtier.
Exterior Surfaces of the Primary Engineering Control (PEC)
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.
Clean Scrub™ Sponge
Low-Lint Hand Drying Wipes and Dispenser
PPE
PREempt ® Plus
Klean Max™ Wall Washing System
Contec ® MicroCinch™ Mop
PeridoxRTU ® Sporicide, Disinfectant, and Cleaner
Amplitude™ EcoCloth™ Wipes
Klean Max™ Wall Washing System
Contact Contec Expert
Featured Products:
Contec ® Critical
Site Sterile Wipes
Contec ® Healthcare TB 1-3300™ Sterile Disinfectant
Easy Reach™ Cleaning Tool (Sterile)
Best Practice Elements:
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•
Minimize storage inside PECs to maximize the size of the Direct Compounding Area (DCA) where critical sites are exposed to unidirectional HEPA-filtered air (first air).
Keep packs of presaturated wipes and anything hanging from the IV bar to the left or right of the DCA.
Avoid wall mounted bins inside PECs (especially CAIs or
CACIs) as they cause significant disruption in airflows and may make identification of an appropriately sized DCA difficult.
DCA (Direct Compounding Area) and the Interior of the PEC (Primary Engineering Control)
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).
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.
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.
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For the most efficient workflow, place a pass-through from the non-classified pharmacy prep area to the buffer room. If you decide to place the pass-through in the anteroom, it must be placed on the “dirty” side of the anteroom to the buffer room, so it is accessible without garbing from the anteroom.
Learn about critical cleaning zones in compounding pharmacies and considerations that will help pharmacists maintain a state of control.
Click circles to learn more
Click on the tabs to explore the cleanroom
Critical Cleaning Zones
DCA (Direct Compounding Area) and the Interior of the Primary Engineering Control (PEC)
Exterior Surfaces of the Primary Engineering Control (PEC)
Buffer Room
Anteroom
Anteroom
Featured Products:
Best Practice Elements:
•
•
•
•
•
Clean and disinfect the sink every day. Scrub the visible portion of the drain and discard any strainer if present.
Fill the drain at the end of cleaning with an EPA-registered sporicidal disinfectant cleaner (like PeridoxRTU®) and allow it to dwell on a weekly or monthly basis.
Use a low-lint wipe dispenser to dispense wipes for hand drying. These devices should be such that 1 or 2 wipes are easy to dispense, and the pack of wipes is encased in plastic and closed to prevent contamination and reduce particulates.
Mount a clock with a second hand over the sink so that staff can easily time the lathering time of 30 seconds. This clock is best hung on the wall and removed at least monthly to clean and disinfect the clock and wall surfaces beneath with an EPA-registered sporicidal disinfectant cleaner.
Place a wall-mounted mirror (sealed with caulk around the perimeter of the mirror) where head covers are donned to facilitate verification of proper placement.
Anteroom
Buffer Room
Featured Products:
Best Practice Elements:
•
•
•
•
•
Have a staging table available for operators to stage components as they go in and out of the PEC to improve efficiency of workflow and CSP staging.
Locate a worktable in the buffer room (or other location where sterile gloves are donned) for donning gloves on which can be placed alcohol-based hand rub and sterile IPA.
Walk and move slowly while in the buffer room (especially nearby the PEC) to minimize particulate generation.
Consider prohibiting music in the buffer room to
increase worker concentration. Music volume is often turned up high to overcome the sound of the HVAC resulting in a noise decibel level that requires workers to raise their voices to be heard. Raised voices not only increases particle generation but background noise of that levels can cause long term hearing loss.
Provide stools that are height adjustable, have a back support, and do not have wheels. Eliminating wheels from stools saves valuable cleaning time and reduces potential bioburden.
Buffer Room
Exterior Surfaces of the Primary Engineering Control (PEC)
DCA (Direct Compounding Area) and the Interior of the Primary Engineering Control (PEC)