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Overview
USP CHAPTER <797>
USP CHAPTER <800>
Contec Healthcare provides products for cleaning and disinfection and related work practices for sterile compounding.
We are ready to assist sterile compounding operations to adapt to the new standards quickly and seamlessly in the areas of cleaning and disinfecting, residue removal, hand hygiene, garbing, and material handling.
USP Chapter <797>
The United States Pharmacopeia (USP)
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USP CHAPTER <825>
PROSAT® Sterile™ HCPS0002IR Wipes
Featured Product:
Use on items being loaded into PECs and inside PECs
Location:
Before placing items into PECs, before and after compounding on the PEC work surface and daily after cleaning and disinfection to remove residues.
Frequency:
See product details
MicroCinch™ Mop
Featured Product:
Floors in the anteroom, buffer room and SCA
Location:
At least daily
Frequency:
See product details
Klean Max™ Wall Washing System
Featured Product:
Walls and ceilings in the anteroom, buffer room and SCA
Location:
At least monthly
Frequency:
See product details
Contec® Healthcare TB1-3300™ Disinfectant Wipes, Sterile
Featured Product:
Inside PECs, work surfaces outside PEC, pass-through chamber, high touch surfaces, and floors in the anteroom, buffer room and SCA
Location:
At least daily
Frequency:
See product details
NEXT: USP CHAPTER <800>
PeridoxRTU®, Sterile
Featured Product:
Inside PECs and any equipment inside, work surfaces outside PEC, pass-through chamber, high touch surfaces, walls, ceilings, storage shelving and bins, equipment and furniture, and floors in the anteroom, buffer room and SCA
Location:
Monthly where compounding is limited to Category 1 and 2 CSPs; Weekly for facilities where Category 3 CSPs are prepared
Frequency:
See product details
PREempt® Plus
Featured Product:
Work surfaces outside PEC, pass-through chamber, high touch surfaces, and floors in the anteroom, buffer room and SCA
Location:
At least daily
Frequency:
See product details
Contec Healthcare's Solutions
Download Contec's USP <797> Guide
Contec Healthcare
By using our experience and valued customer feedback, our products meet the specific needs of compounding operations and we pledge to continue to adapt as science and demands in the field evolve.
Contec is ready to assist sterile compounding operations to adapt to the new standards quickly and seamlessly in the areas of “personal hygiene and garbing” (Section 3), “cleaning, disinfecting and applying sporicidal agents and sterile IPA” (Section 7) and “introducing items into the SEC and PEC” (Section 8) as well general provisions of the chapter. View our USP <797> compliant product offerings below, where to use them, and how often you should use them.
The updated protocols in Chapter <797> contain minimum standards required for pharmacy sterile compounding sterile preparations and will become official on November 1, 2023.
Contec Healthcare
Explore Our Products and Solutions
Overview
USP CHAPTER <797>
USP CHAPTER <800>
USP CHAPTER <825>
Featured Product:
Location:
Frequency:
See product details
Featured Product:
Location:
Frequency:
See product details
Featured Product:
Location:
Frequency:
See product details
Featured Product:
Location:
Frequency:
See product details
Featured Product:
Location:
Frequency:
See product details
NEXT: USP CHAPTER <800>
Cleaning and Disinfection
Material Handling
Nonhazardous Garbing
PECs (Primary Engineering Controls)
SECs (Secondary Engineering Controls)
Operator Conduct
Contact us
Best Practices
Get Resource
General Guidance for Daily and Monthly Cleaning and Disinfecting
Cleaning and Disinfection
1
2
3
4
5
Best Practices | Cleaning and Disinfection
1
Perform daily cleaning at the end of the compounding day to allow the room to rest in a clean state. For 24-hour pharmacies, plan a time to clean each day. Know how long it takes to clean your PECs, buffer, and anteroom. Allow sufficient time for cleaning and drying since the room may not be used for compounding until it is dry. This requires planning with EVS and alternate compounding locations for stat orders which may occur during the cleaning time. Remember cleaning and disinfecting is every bit as important as compounding.
2
Store equipment and supplies used for cleaning the cleanroom suite or the SCA in that location. Do not use items from other locations.
3
Though not required, the use of an EPA-registered one-step disinfectant cleaner streamlines cleaning processes in the compounding area since these agents clean and disinfect with one step as long as the manufacturer’s dwell time is achieved.
4
Generally clean top to bottom, left to right and back to front. Use slightly overlapping strokes, never circular motions.
5
When disinfecting hard, non-porous surfaces inside the sterile compounding suite. Achievement of dwell time is now required by USP 797. Follow the manufacturer’s directions to ensure your staff know the dwell time of the disinfectant cleaners used at your facility.
Cleaning and Disinfection
Best Practices
Get Resource
Staging Components for Entry to the PEC
Material Handling
1
2
3
4
5
Best Practices | Material Handling
1
Wipe (do not spray) all surfaces of any supply/component going into the buffer room with an EPA-registered one-step
sporicidal disinfectant cleaner ensuring dwell time is achieved. Though sterile IPA and germicidal cleaning agents are permitted, they will not remove the spores from packaging, potentially introducing contamination into the buffer room or beyond the perimeter of the SCA. Depending on your facility this activity may take place in the prep area directly outside the anteroom or on the dirty side of the anteroom.
2
Treat the staging table in the same way the deck of the PEC is treated. Only the paper documentation (if any) and components for one batch or prep should be on the staging table. Wipe the top of the staging table with sterile IPA before placing components/documentation for the next batch/prep on it. Failure to routinely clean, disinfect and sanitize the staging table used by the operator to stage components going in and out of the PEC has often been a cause of surface sampling excursions inside the PEC.
3
If transfer into the buffer room takes place on the dirty side of the anteroom where items will be placed onto a clean cart on
the clean side of the LOD (Line of Demarcation) after wiping, it is strongly recommended that a mask and head cover be donned to eliminate excessive particles being introduced into the anteroom if material handling a larger number of items. Remember to always wear gloves when wiping items.
4
After a batch/prep is completed and exits the PEC, place the finished CSP, documentation and any other items back in the bin on the staging table and place it in the pass through or staging location to exit the buffer room. Wipe the top shelf with sterile 70% IPA and bring the next bin of staged components up onto the shelf.
5
When disinfecting hard, non-porous surfaces inside the sterile compounding suite. Achievement of dwell time is now required by USP 797. Follow the manufacturer’s directions to ensure your staff know the dwell time of the disinfectant cleaners used at your facility.
Material Handling
Best Practices
Get Resource
Tips for Eyeglasses, Gowning, Face Masks, and Gloving
Nonhazardous Garbing
1
2
3
4
5
Best Practices | Nonhazardous Garbing
1
Clean personal eyeglasses before entering anteroom. Use individually wrapped lens cleaner packets to clean lenses (IPA
and cleaning agents can damage most lenses). After cleaning the lenses, wipe the frames with an EPA-registered germicidal cleaner disinfectant (like PREempt Plus).
2
Face masks must be donned with the folds facing down on the outside of the mask creating little “pockets” to catch exhalations of breath on the inside of the mask. Cleanroom grade masks are best since they have a coating on the outside of the mask that reduces the potential for moisture bleed through. Either a loop or tie mask is fine if it fits snugly without any gaps. Bend the metal bar so that it molds to the bridge of the nose. While holding the top of the mask, pull the bottom of the mask down underneath the chin. Use your time to garb properly. Once garb is donned, it should not require adjustment and touching garb must be avoided.
3
When donning a gown*, leave wrists exposed and do not put the thumb loop in place until after hands are sanitized with the
alcohol-based hand gel immediately before the sterile gloves are donned.
*Contec Healthcare provides cleanroom-specific frocks as part of our line of Garb & PPE to protect the controlled environment from personnel contamination.
4
Gown reuse in Cleanroom Suites: Though USP <797> permits reuse of the gown* by the same individual for 1 shift provided the gown is stored in a “classified” area, consider disposing the gown and not reusing. The arms of the gown are placed directly inside the PEC, so any contamination the gown picks up while it is hanging, is brought directly into the DCA. If your facility does reuse gowns, gowns are best hung on the clean side of the anteroom far away from potential contact with water.
*Contec Healthcare provides cleanroom-specific frocks as part of our line of Garb & PPE to protect the controlled environment from personnel contamination.
5
Remove sterile gloves from storage before applying alcohol-based hand gel. Before removing the outer wrap from the sterile glove package, check the integrity of the packaging and the expiration date. Discard if the package is damaged or the expiration date has passed. Place the unopened sterile glove inner package on the gloving table. Then apply alcohol-based hand gel.
Nonhazardous Garbing
Best Practices
Get Resource
Cleaning and Disinfection of PECs
PECs (Primary Engineering Controls)
1
2
3
4
5
Best Practices | PECs (Primary Engineering Controls)
1
Ensure that that the head of the person cleaning (or compounding) does not break the front plane of the LAFW. To avoid this, use an Easy Reach tool to effectively reach all surfaces in the PEC. It is best to house the Easy Reach tool inside each PEC instead of using one Easy Reach tool and bringing it in and out of each PEC each time.
2
USP <797> requires the use of sterile cleaning agents and applicators inside the PEC. Use the sterile packaging from applicator heads (such as the Easy Reach mop head) to replace the zip lock bag approach to saturating applicators.
3
The sequence of cleaning inside an LAFW is irregular surfaces (IV pole, hangers, bolts, etc.), ceiling, back, sides, items on the deck, and then the deck itself.
4
When cleaning a RABS type CAI, there are additional surfaces to clean and disinfect which include the interior of the view screen and the glove sleeves and attachments. First, clean the interior view screen. Then, clean the entire length of the sleeves followed by the deck. Lastly remove the hands from the glove port to clean and disinfect. Follow this order of cleaning to avoid contaminating the deck with trailing sleeves and gloves.
5
Conduct new smoke studies in the PEC if the size or location of the DCA changes due to increased numbers of cleaning items being stored in the PEC. Be wary of storing containers of daily disinfectants in the PEC as these items will cause an additional zone of turbulence.
PECs (Primary Engineering Controls)
Best Practices
Cleaning and Disinfection of SECs
SECs (Secondary Engineering Controls)
1
2
3
4
5
Best Practices | SECs (Secondary Engineering Controls)
1
Limiting the number of wet surfaces at one time will reduce the odors generated by sporicidal agents. To mitigate the odor during monthly cleaning, wet only the ceiling and 1 or 2 walls at a time. While the ceiling is wet, clean a piece of furniture, until the ceiling dries and the odor disperses. Continue in this manner until all surfaces of the room have been cleaned and disinfected.
2
Before cleaning walls, clean all irregular surfaces (air returns, outlets, shelving, ports, etc.) by hand with a wipe then clean the flat surfaces. When cleaning the flat surfaces of walls, use slightly overlapping strokes to ensure complete coverage with the disinfectant cleaner.
3
For the best results when cleaning floors, begin at the farthest corner of the room and mop backward toward the door using
slightly overlapping strokes, in an S-curve pattern, ensuring complete coverage.
4
If a tacky mat is installed, place it immediately outside of the anteroom or SCA entrance. Ensure mats are installed “long ways” not across the door span to ensure multiple footfalls on the mat. Also make sure the tacky mat surfaces are changed at least once per day. Depending on the number of people and times they enter, these mats may require multiple changes per day.
5
USP <797> does not require residue removal inside the SEC. However, sIPA can be used to remove residues from the windows in the walls for aesthetic reasons, if desired. It is also strongly recommended that work surfaces are wiped with sIPA regularly throughout the compounding day. Depending on the daily cleaning agent used on floors, it may be desirable to remove residue on floors weekly if there is visible residue or the floors feel sticky. Use sterile water for irrigation for this purpose.
SECs (Secondary Engineering Controls)
Best Practices
Operator Conduct in the Compounding Area
Operator Conduct
1
2
3
4
5
Best Practices | SECs (Secondary Engineering Controls)
1
Ensure that no worker or visitor enters compounding areas (anteroom, cleanroom, SCA) without being properly garbed. Consider a written policy that governs who may enter these areas what garb they must wear, who may clear visitors and how they are escorted and supervised.
2
Do not talk while compounding to reduce the potential for error and decrease particulate generation to the DCA with outgassing from the mask.
3
Minimize trips in and out of the anteroom and buffer room with organization and material handling that ensures the right number and kind of components for each prep/batch.
4
Consider prohibiting music in the buffer room and SCA to prevent erosion in 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.
5
Sanitize gloves with sterile IPA before manipulating pouches of presaturated sterile wipes. When removing a wipe, touch only one wipe at a time, ensure the package is “burped” to remove air and close the resealable tab completely so that wipes do not dry out.
Operator Conduct
Cleaning and Disinfection
Material Handling
Nonhazardous Garbing
PECs (Primary Engineering Controls)
SECs (Secondary Engineering Controls)
Operator Conduct
Contact us
Best Practices
Get Resource
General Guidance for Daily and Monthly Cleaning and Disinfecting
Cleaning and Disinfection
1
2
3
4
5
Best Practices | Cleaning and Disinfection
1
Perform daily cleaning at the end of the compounding day to allow the room to rest in a clean state. For 24-hour pharmacies, plan a time to clean each day. Know how long it takes to clean your PECs, buffer, and anteroom. Allow sufficient time for cleaning and drying since the room may not be used for compounding until it is dry. This requires planning with EVS and alternate compounding locations for stat orders which may occur during the cleaning time. Remember cleaning and disinfecting is every bit as important as compounding.
2
Store equipment and supplies used for cleaning the cleanroom suite or the SCA in that location. Do not use items from other locations.
3
Though not required, the use of an EPA-registered one-step disinfectant cleaner streamlines cleaning processes in the compounding area since these agents clean and disinfect with one step as long as the manufacturer’s dwell time is achieved.
4
Generally clean top to bottom, left to right and back to front. Use slightly overlapping strokes, never circular motions.
5
When disinfecting hard, non-porous surfaces inside the sterile compounding suite. Achievement of dwell time is now required by USP 797. Follow the manufacturer’s directions to ensure your staff know the dwell time of the disinfectant cleaners used at your facility.
Cleaning and Disinfection
Best Practices
Get Resource
Staging Components for Entry to the PEC
Material Handling
1
2
3
4
Best Practices | Material Handling
1
Wipe (do not spray) all surfaces of any supply/component going into the buffer room with an EPA-registered one-step sporicidal disinfectant cleaner ensuring dwell time is achieved. Though sterile IPA and germicidal cleaning agents are permitted, they will not remove the spores from packaging, potentially introducing contamination into the buffer room or beyond the perimeter of the SCA. Depending on your facility this activity may take place in the prep area directly outside the anteroom or on the dirty side of the anteroom.
2
Treat the staging table in the same way the deck of the PEC is treated. Only the paper documentation (if any) and components for one batch or prep should be on the staging table. Wipe the top of the staging table with sterile IPA before placing components/documentation for the next batch/prep on it. Failure to routinely clean, disinfect and sanitize the staging table used by the operator to stage components going in and out of the PEC has often been a cause of surface sampling excursions inside the PEC.
3
If transfer into the buffer room takes place on the dirty side of the anteroom where items will be placed onto a clean cart on the clean side of the LOD (Line of Demarcation) after wiping, it is strongly recommended that a mask and head cover be donned to eliminate excessive particles being introduced into the anteroom if material handling a larger number of items. Remember to always wear gloves when wiping items.
4
After a batch/prep is completed and exits the PEC, place the finished CSP, documentation and any other items back in the bin on the staging table and place it in the pass through or staging location to exit the buffer room. Wipe the top shelf with sterile 70% IPA and bring the next bin of staged components up onto the shelf.
5
When disinfecting hard, non-porous surfaces inside the sterile compounding suite. Achievement of dwell time is now required by USP 797. Follow the manufacturer’s directions to ensure your staff know the dwell time of the disinfectant cleaners used at your facility.
Material Handling
Best Practices
Get Resource
Tips for Eyeglasses, Gowning, Face Masks, and Gloving
Nonhazardous Garbing
1
2
3
4
5
Best Practices | Nonhazardous Garbing
1
Clean personal eyeglasses before entering anteroom. Use individually wrapped lens cleaner packets to clean lenses (IPA and cleaning agents can damage most lenses). After cleaning the lenses, wipe the frames with an EPA-registered germicidal cleaner disinfectant (like PREempt Plus).
2
Face masks must be donned with the folds facing down on the outside of the mask creating little “pockets” to catch exhalations of breath on the inside of the mask. Cleanroom grade masks are best since they have a coating on the outside of the mask that reduces the potential for moisture bleed through. Either a loop or tie mask is fine if it fits snugly without any gaps. Bend the metal bar so that it molds to the bridge of the nose. While holding the top of the mask, pull the bottom of the mask down underneath the chin. Use your time to garb properly. Once garb is donned, it should not require adjustment and touching garb must be avoided.
3
When donning a gown*, leave wrists exposed and do not put the thumb loop in place until after hands are sanitized with the alcohol-based hand gel immediately before the sterile gloves are donned.
*Contec Healthcare provides cleanroom-specific frocks as part of our line of Garb & PPE to protect the controlled environment from personnel contamination.
4
Gown reuse in Cleanroom Suites: Though USP <797> permits reuse of the gown* by the same individual for 1 shift provided the gown is stored in a “classified” area, consider disposing the gown and not reusing. The arms of the gown are placed directly inside the PEC, so any contamination the gown picks up while it is hanging, is brought directly into the DCA. If your facility does reuse gowns, gowns are best hung on the clean side of the anteroom far away from potential contact with water.
*Contec Healthcare provides cleanroom-specific frocks as part of our line of Garb & PPE to protect the controlled environment from personnel contamination.
5
Remove sterile gloves from storage before applying alcohol-based hand gel. Before removing the outer wrap from the sterile glove package, check the integrity of the packaging and the expiration date. Discard if the package is damaged or the expiration date has passed. Place the unopened sterile glove inner package on the gloving table. Then apply alcohol-based hand gel.
Nonhazardous Garbing
Best Practices
Cleaning and Disinfection of PECs
PECs (Primary Engineering Controls)
1
2
3
4
5
Best Practices | PECs (Primary Engineering Controls)
1
Ensure that that the head of the person cleaning (or compounding) does not break the front plane of the LAFW. To avoid this, use an Easy Reach tool to effectively reach all surfaces in the PEC. It is best to house the Easy Reach tool inside each PEC instead of using one Easy Reach tool and bringing it in and out of each PEC each time.
2
USP <797> requires the use of sterile cleaning agents and applicators inside the PEC. Use the sterile packaging from applicator heads (such as the Easy Reach mop head) to replace the zip lock bag approach to saturating applicators.
3
The sequence of cleaning inside an LAFW is irregular surfaces (IV pole, hangers, bolts, etc.), ceiling, back, sides, items on the deck, and then the deck itself.
4
When cleaning a RABS type CAI, there are additional surfaces to clean and disinfect which include the interior of the view screen and the glove sleeves and attachments. First, clean the interior view screen. Then, clean the entire length of the sleeves followed by the deck. Lastly remove the hands from the glove port to clean and disinfect. Follow this order of cleaning to avoid contaminating the deck with trailing sleeves and gloves.
5
Conduct new smoke studies in the PEC if the size or location of the DCA changes due to increased numbers of cleaning items being stored in the PEC. Be wary of storing containers of daily disinfectants in the PEC as these items will cause an additional zone of turbulence.
PECs (Primary Engineering Controls)
Cleaning and Disinfection of SECs
Best Practices
SECs (Secondary Engineering Controls)
1
2
3
4
5
Best Practices | SECs (Secondary Engineering Controls)
1
Limiting the number of wet surfaces at one time will reduce the odors generated by sporicidal agents. To mitigate the odor during monthly cleaning, wet only the ceiling and 1 or 2 walls at a time. While the ceiling is wet, clean a piece of furniture, until the ceiling dries and the odor disperses. Continue in this manner until all surfaces of the room have been cleaned and disinfected.
2
Before cleaning walls, clean all irregular surfaces (air returns, outlets, shelving, ports, etc.) by hand with a wipe then clean the flat surfaces. When cleaning the flat surfaces of walls, use slightly overlapping strokes to ensure complete coverage with the disinfectant cleaner.
3
For the best results when cleaning floors, begin at the farthest corner of the room and mop backward toward the door using slightly overlapping strokes, in an S-curve pattern, ensuring complete coverage.
4
If a tacky mat is installed, place it immediately outside of the anteroom or SCA entrance. Ensure mats are installed “long ways” not across the door span to ensure multiple footfalls on the mat. Also make sure the tacky mat surfaces are changed at least once per day. Depending on the number of people and times they enter, these mats may require multiple changes per day.
5
USP <797> does not require residue removal inside the SEC. However, sIPA can be used to remove residues from the windows in the walls for aesthetic reasons, if desired. It is also strongly recommended that work surfaces are wiped with sIPA regularly throughout the compounding day. Depending on the daily cleaning agent used on floors, it may be desirable to remove residue on floors weekly if there is visible residue or the floors feel sticky. Use sterile water for irrigation for this purpose.
SECs (Secondary Engineering Controls)
Best Practices
Operator Conduct in the Compounding Area
Operator Conduct
1
2
3
4
5
Best Practices | SECs (Secondary Engineering Controls)
1
Ensure that no worker or visitor enters compounding areas (anteroom, cleanroom, SCA) without being properly garbed. Consider a written policy that governs who may enter these areas what garb they must wear, who may clear visitors and how they are escorted and supervised.
2
Do not talk while compounding to reduce the potential for error and decrease particulate generation to the DCA with outgassing from the mask.
3
Minimize trips in and out of the anteroom and buffer room with organization and material handling that ensures the right number and kind of components for each prep/batch.
4
Consider prohibiting music in the buffer room and SCA to prevent erosion in 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.
5
Sanitize gloves with sterile IPA before manipulating pouches of presaturated sterile wipes. When removing a wipe, touch only one wipe at a time, ensure the package is “burped” to remove air and close the resealable tab completely so that wipes do not dry out.
Operator Conduct
Best Practices Guidance
Best Practices Guidance