Medical Air Solutions, LLC

USP Chapter <797> Proposed Revisions

(NOTE:  This page is for information purposes only.  The final USP <797> standard was issued on December 3, 2008)

Medical Air Solutions, LLC. attended and participated in the Q & A session following the USP Webinar  (Web Seminar) held on June 7, 2006.  The Webinar was hosted by the United States Pharmacopeia (USP) to provide information and discussion on the proposed revisions and clarifications to USP Chapter <797>.  The proposed revisions with and without markup are available at not charge on the USP web site (http://www.usp.org/USPNF/pf/generalChapter797.html).  A detailed USP <797> Guidebook is available for $79.00 and can be ordered online on the same web page for those of you that would like to procure this document.

Introduction

It should be noted that the proposed USP <797> revisions are just that, proposed revisions.  They are not in effect at this time and there will be a period of time where public comment will be accepted either by formal letter or by the online form provided on the USP web site.  MAS shall present, in this document, detailed information about these proposed changes and clarifications.  We will also provide the present requirements with our commentary and opinions on the engineering and economical effect these changes and clarifications will incur.

For those of you that already have an MAS proposal, if you are not performing high risk CSP, MAS does not plan to change your present proposal.  (For a list of high risk drugs, go to the NIOSH web site at www.cdc.gov/niosh/docs/2004-165/.  It will meet both the present and all the revisions in discussion at this time.)  Those of you that perform high risk (identified as “hazardous on the NIOSH web site) CSP may need a revision to your proposal provided you would like to meet the proposed standards that we and USP feels will be adopted.

There is one revision where the creation of an Anteroom or an Ante-area is considered an option for the low and/or medium risk CPS.  MAS will still rely on the unofficial criteria of the “Low volume/High volume” (less than 15 CSP = low volume, 15 or greater = high volume) to determine the need for a hard wall separating the Anteroom/Ante-area and the Buffer Zone.  We have presented a comment to USP regarding the air mixing problems of having multiple LAFWs in a Buffer Zone with a large opening to an Ante-area.  MAS will continue to provide the highest quality engineering solutions for the Pharmacy that will meet or exceed the basic standards while doing so in a cost efficient manner.

There has been some confusion about the necessity of upgrading the compounding areas of the Pharmacy since the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will not be surveying this area for compliance with USP <797>.  One professional organization actually instructed their members that they could probably cease all upgrade preparations since there would be no one to enforce this new standard.  This was a tad premature.  The U. S. Food and Drug Administration (FDA) has deemed USP <797> as a “Standard of Care” and will expect all state Boards of Pharmacy to enforce compliance.  To quote the USP Guidebook:

“Thus, while the FDA generally defers to the states to regulate the practice of pharmacy and other health professions, it takes a keen interest in the quality and safety of the compounded preparations that reach patients.  The FDA will act with states in investigating allegations of poor quality compounded drugs, but is willing and able under the FFDCA [Federal Food, Drug and Cosmetic Act] to act on its own initiative.  The FDA intends to continue to work with states, but if a state is unwilling or unable to join the Agency’s efforts, the FDA may choose to act unilaterally to protect the public health from compounded drugs that pose unreasonable risks.”

This is not a case where you have to “read between the lines”.  The FDA will enforce compliance.  Also, rates for insurance premiums may be based of your compliance and, in the event of a lawsuit, USP Chapter <797> would be held up as a “standard of care”.  If your pharmacy is involved in litigation and was not compliant and up to the standard, the result would be clear.  You would lose.

MAS will continue to work to provide basic design services and medical-grade equipment that will ensure your pharmacy will meet and/or exceed USP <797>.  With few exceptions, our designs do not affect the actual structure (building).  There are some states and local governments that may require an architect and/or engineer to approve any pharmacy renovation.  MAS will work with the contractor or pharmacy to gain these approvals and provide assistance to the contractor during renovation or construction.

The following is basic information from the Webinar and how we at MAS propose to implement these changes in our design and equipment proposals.  We strongly recommend that the USP Guidebook is purchased to have the complete text of the proposed revisions and clarifications.

The information provided here will be in the following format:

Type:  (New Standard, Revision or Clarification)

Description:  (An explanation of the type of revision proposed)

Exceptions:  (Any exceptions to the description above)

Adoption:  (Highly Probable, Probable, Possible or Unlikely)

MAS Comments:  (Our comments on the proposed addition, change or clarification)

Some of the items presented here will not necessarily be associated with engineering design.  We are providing some of the more important information in condensed form for all interested parties.  Much of the explanations for the risk types and descriptions of the various elements of USP <797> have changed which is why we strongly suggest you either download the free documents or, better yet, purchase the Guidebook.

If you have any questions regarding the physical upgrade to your pharmacy please feel free to call us at 800-645-1059 or call our engineering direct at 770-377-3884.

Definitions

Some changed and new definitions are included in the proposed revision.  We are not going to list all, just those that apply to what is relevant to an engineering and equipment proposal you have or would receive from MAS.

Anteroom — An anteroom is an ISO Class 8 (see Table 1) or better area where personnel perform hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities. It is also a transition area that 1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and 2) that reduces the need for the heating, ventilating and air conditioning (HVAC) control system to respond to large disturbances.

Biological Safety Cabinet, Class II (BSC) — The BSC is a ventilated cabinet for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward HEPA filtered laminar airflow for product protection, and HEPA filtered exhausted air for environmental protection.

Buffer Area, Buffer or Core Room, Buffer or Cleanroom Areas, Buffer Room Area, Buffer or Clean Area — This is an ISO Class 7 (see Table 1) area where the primary engineering control area (see below) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs.

Compounding Aseptic Isolator (CAI) — The CAI is a form of barrier isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless it has first passed through a microbially retentive filter (HEPA minimum). [Note: This is equivalent to a glove box – MAS]

Laminar Airflow Workstation (LAFW) — [Not in the USP revision – this has been added by MAS] The LAFW is a cabinet for personnel, product, and environmental protection having an open front with outward and/or downward HEPA filtered laminar airflow for product protection.

Negative Pressure Room — A room that is at a lower pressure compared to adjacent spaces and, therefore, the net flow of air is into the room.

Primary Engineering Control — It is a device or room that provides an ISO Class 5 (see Table 1) environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), and compounding aseptic isolators (CAIs).

Positive Pressure Room — A positive pressure room is one that is at a higher pressure compared to adjacent spaces and, therefore, the net airflow is out of the room.

Secondary Engineering Control — [Not in the USP revision – this has been added by MAS] It is a room that provides an ISO Class 7 or ISO Class 8 (see Table 1) environment for the placement of primary engineering control devices that include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), and compounding aseptic isolators (CAIs).

Unidirectional Flow — (see U.S. Food and Drug Administration, Guidance for Industry Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice) — An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. [This type airflow is also known as “laminar flow or laminar airflow” – MAS]

Additions, Revisions and Clarifications

As stated above, some of the additions, revisions and changes listed here are not necessarily of an engineering nature.  We have included these to make a more comprehensive presentation.

Type:  New Standard for Immediate Use CSPs

Description:  These CSPs are exempted if there purpose is for emergency or immediate patient care.  It applies to all risk levels provided.

1.        Simple aseptic measuring and transfer with 3 or less sterile non-hazardous commercial or radiopharmaceutical drug products.

2.        Unless required for the preparation, the preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour.

3.        At no point during preparation and prior to administration are critical surfaces and ingredients of the CSP directly exposed to contact contamination

4.        Administration begins not later than one (1) hour following the start of preparing the CSP.

5.        When the CSP is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, all pertinent labeling must be completed.

6.        Administration must begin within one (1) hour following the start of preparing the CSP.

(Note:  This is a condensed version.  See USP document for more detailed information.)

Exceptions:  Hazardous drugs such and cancer chemotherapy and those listed on the NIOSH list.

Adoption:  Highly Probable

MAS Comments:  Number 3 is critical here.  These are not being compounded in an ISO 5 environment so extra caution is required to ensure the immediate use CSP does not come into contact with other contaminated items or surfaces.

Type:  New Standard for Hazardous High Risk Drug Storage

Description:  Hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Such storage is preferably within a containment area such as a negative pressure room. The storage area must have sufficient general exhaust ventilation, at least 12 air exchanges per hour (ACPH or ACH) to dilute and remove any airborne contaminants.  Storage is preferably in a negative pressure area with exhaust to the outside.  These drugs shall be compounded within an ISO 5 BSC or CAI within a negative pressure room that is an ISO Class 7.  The anteroom to this CSP room shall be a positive pressure ISO Class 8.

(Note: Information for compounding radiopharmaceuticals is contained in USP <823>)

Exceptions:  If the room where the ISO 5 BSC or CAI is located is not a defined Buffer Zone, it still must have a minimum -0.01 in. W. C. (Water Column) negative pressure and 12 ACH (Air Changes per Hour (ACPH or ACH).

Adoption:  Probable

MAS Comments:  Storage of these type drugs will depend on the volume that is being stored.  A small segregated room for higher storage volume may be indicated or, for small volumes, a negative pressure cabinet may suffice.  The room or cabinet must be vented to the outside.

Type:  New and Clarification for Placement of Primary Engineering Controls (LAFW, BSC and CAI)

Description:  All Primary Engineering Controls (LAFW, BSC and CAI) shall be placed in an ISO 7 Buffer Zone for all risk level CSP.  Only authorized personnel shall have access to this area when CSP operations are taking place.

Exceptions:  Some smaller compounding pharmacies have or are considering utilizing a CAI (glove box) for low and medium risk CSP in an area that does not have Secondary Engineering Controls.  This is permitted contingent upon the manufacturer of the CAI supplying testing/study documentation and written assurance that no foreign material can enter the CAI during the transfer of the CSP elements from the room into the CAI.

Adoption:  Highly Probable

MAS Comments:  After consulting the MAS legal representative, it is highly unlikely that any company or contracted lawyer would advise or permit any manufacturer to issue such documentation and assurances.  The bottom line is you must place your Primary Engineering Control(s) in a room with Secondary Engineering Controls.

MAS has always advocated placing Primary Engineering Control(s) in an ISO 7 Buffer Zone.  We also advocate having all Buffer Zones enclosed with a hard wall except where only low volumes of low and medium risk CSP are performed.

Type:  New and Clarification of the ISO 7 Positive Pressure Buffer Zone

Description:  The ISO 7 Buffer Zone shall be segregated from any surrounding unclassified areas and be accessed through an Anteroom.  When the Buffer Zone is enclosed by walls it shall maintain a positive pressure of +0.02” - +0.05“ W. C. and have a minimum of 30 ACH.  Keep in mind this area is virtually identical to the physical design of a standard surgical suite (operating room).

If the Buffer Zone is segregated from an Ante-area by a demarcation line or soft barrier (i.e., plastic strips) then the air movement from the Buffer Zone to the Ante-area shall be a minimum of 40 feet per minute (FPM – this can be measured accurately by a thermal anemometer).

The minimum 30 ACH shall be delivered either by the Secondary Engineering Control device(s) (usually ceiling mounted laminar airflow units) or a combination of the Primary and Secondary Engineering Controls to achieve the 30 ACH.  The air being provided and exchanged via the Primary and Secondary Engineering Controls shall be through a HEPA (High Efficiency Particulate Air) filter with a minimum starting efficiency of 99.97% at 0.3 microns whose efficiency shall be confirmed on a yearly basis.

The exhaust from these rooms shall be near the floor of the ISO 7 area.  Exhausting air via ceiling return should be avoided whenever possible. 

Exceptions:  None

Adoption:  Highly Probable

MAS Comments:  MAS has extensive experience in designing and, via our contractor partners, renovating rooms and areas to achieve both positive and negative pressure, ultra-clean indoor air environments.  We currently design the positive pressure ISO 7 Buffer Zone to provide a target of +0.03” W. C. (in an enclosed room) and 45 ACH in any Buffer Zone.  We also build in enough excess capacity to achieve 50-60 ACH when possible.  The LAFW, BSC and/or CAIs shall have more than sufficient supply of ultra-clean air to pass through the HEPA filters in these units.  It should be noted that the pressure in the Buffer Zone must always be significantly higher than the Anteroom when there is a hard wall segregating these two areas.

In enclosed ISO 7 Buffer Zones, the differential pressure (dP) should be continuously monitored via a pressure sensing device.  Keep in mind that the differential pressure in the ISO 7 room should be compared to a non-pressurized adjacent area such as the common pharmacy area or a hallway and not the Anteroom.  The same applies to monitoring the differential pressure of the Ante-area or Anteroom.

Airflow dynamics (air mixing and air movement) is an integral part of the design of any pressurized room needing an ultra-clean air environment.  We design with considerations of where doors, pass-throughs, other CAIs and any other physical barriers that may be present.  The primary concern is to evaluate what the airflow patterns will be after the installation of the Secondary Engineering Controls and design so that the LAFW, BSC and/or CAIs are protected from any source of contamination.

The installation of return air grilles near the floor is usually a difficult procedure due to the construction and thickness of an existing wall and may be prohibitively costly.  In some cases it may be unavoidable to have return air exiting the room via a ceiling or upper wall return as long as its placement does not allow the possible contamination of the ISO 5 units.  MAS will usually have the excess air exit the room under the entrance door to the ISO 7 Buffer Zone into the Anteroom.

Type:  New ISO 7 Negative Pressure Buffer Zone

Description:  The ISO 7 Buffer Zone that is used for High Rick CSP shall be segregated from the Anteroom and any unclassified areas and shall be accessed from the Anteroom.  The Buffer Zone is enclosed by walls and shall maintain a minimum negative pressure of +0.01” W. C. minimum and have a minimum of 12 ACH.  Keep in mind this area is virtually identical to the physical design of standard Airborne Infectious Isolation (AII) room for immunocompromised patients.

The minimum 12 ACH shall be delivered either by the Secondary Engineering Control device (usually ceiling mounted laminar airflow units) or a combination of the Primary and Secondary Engineering Controls to achieve the 12 ACH.  The air being provided and exchanged via the Primary and Secondary Engineering Controls shall be through a HEPA (High Efficiency Particulate Air) filter with a minimum starting efficiency of 99.97% at 0.3 microns whose efficiency shall be confirmed on a yearly basis.

The exhaust from these rooms shall be near the floor of the ISO 7 area.  Exhausting air via ceiling return should be avoided whenever possible.  Exhaust should be vented to the outside.

Exceptions:  None

Adoption:  Highly Probable

MAS Comments:  MAS has extensive experience in designing and, via our contractor partners, renovating rooms and areas to achieve both positive and negative pressure, ultra-clean indoor air environments.  We currently design the negative pressure ISO 7 Buffer Zone to provide a target of +0.01” W. C. minimum and 45 ACH in any Buffer Zone.  We also build in enough excess capacity to achieve 50-60 ACH when possible.  The LAFW, BSC and/or CAIs shall have more than sufficient supply of ultra-clean air to pass through the HEPA filters in these units.  It should be noted that the pressure in the Buffer Zone is negative and must always be significantly lower than the positive pressure Anteroom.  There shall always be a hard wall segregating these two areas for High Risk CSP operations.

In enclosed ISO 7 Buffer Zones the differential pressure (dP) should be continuously monitored via a pressure sensing device.  Keep in mind that the differential pressure in the ISO 7 room should be compared to a non-pressurized adjacent area such as the common pharmacy area or a hallway and not the Anteroom.  The same applies to monitoring the differential pressure of the Ante-area or Anteroom.

Airflow dynamics (air mixing and air movement) is an integral part of the design of any pressurized room needing an ultra-clean air environment.  We design with considerations of where doors, pass-throughs, other CAIs and any other physical barriers that may be present.  The primary concern is to evaluate what the airflow patterns will be after the installation of the Secondary Engineering Controls and design so that the LAFW, BSC and/or CAIs are protected from any source of contamination.

The installation of exhaust air grilles (vented to the outside) for a negative pressure room is normally via ceiling grilles.  In this instance, where possible, exhausting the air via return grilles near the floor is desirable.  In some cases it may be unavoidable to have exhaust air exiting the room via a ceiling grille as long as its placement does not allow the possible contamination of the ISO 5 units.  MAS will usually have the make-up air enter the room under the entrance door to the ISO 7 Buffer Zone from the Anteroom.

Type:  New and Clarification of the Ante-area or Anteroom

Description:  An enclosed Anteroom is defined as a positive pressure area with an ISO Class 8 environment maintaining +0.01” W. C. differential pressure.  A negative pressure Buffer Zone for High Risk CSP shall have an Anteroom but an Anteroom for Medium and Low Risk CSP may only need an Ante-area.  The positive pressure in an enclosed Ante-area plus Buffer Zone (no intervening wall) shall be continuously monitored. 

An Ante-area that is not enclosed may have a demarcation line between it and the Buffer Zone but the entire area may be segregated from the adjacent areas.  The Ante-area may be physically separated from the adjacent areas around it with only a demarcation line to segregate it from any surrounding areas.

The segregation of an Ante-area from a Buffer Zone or an area surrounding the Ante-area itself may be as simple as a line painted on the floor or is may be a barrier of plastic strips or another type of soft barrier.

Exceptions:  None

Adoption:  Highly Probable

MAS Comments:  Placing the entire CSP unenclosed area (Buffer Zone and Ante-area) in any location will usually require some type of barrier to segregate the Buffer Zone on at least three sides.  MAS usually recommends that for a low volume of Low and Medium Risk CSP this is acceptable and we always recommend that a barrier of plastic strips be used to separate the Ante-area from the Buffer Zone.  It is usually a good engineering practice to also separate the Ante-area from the adjacent outside areas with this type barrier also.

MAS also recommends that for a high volume of Low and Medium Risk CSP that a hard wall be used to separate the Buffer Zone which creates an Anteroom or Ante-area.  The rationale behind this is that the longer the CSP operation takes place in an open Ante-area/Buffer Zone configuration the higher the possibility for contamination to occur during CSP operations.

We recommend monitoring the pressure in an enclosed Ante-area/Buffer Zone at the entrance to the Ante-area.  This will measure the differential pressure in the entire CSP area only.

For an enclosed Anteroom and an enclosed Buffer Zone we measure the pressure in both areas to ensure that the airflow direction is moving correctly for the CSP area configuration.  In some instances where there are both enclosed High Risk and a Low and Medium Risk Buffer Zones, we will measure the differential pressure in both Buffer Zones and the enclosed Anteroom.  It is vitally important that airflow from a negative pressure Buffer Zone be moving in the correct direction.

Type:  Clarification

Description:  The testing of the Primary Engineering Controls and the particle and pathogen testing has been clarified.  The LAFWs, BSCs and CAIs shall be testing semi-annually to ensure their performance meets published standards.

Particle and pathogen testing shall be on the following schedule:

High Risk:  Once a week for both particle and pathogen testing.  This can be done in-house or by a third party.

Low and Medium Risk:  Once per month for both particle and pathogen testing.  This can be done in-house or by a third party.

Air sampling should be performed utilizing a sampling pump whenever possible such as an Andersen air sampler.  A minimum recommended sampling time is 1 hour.  The results of this testing should be tracked so that any trends that would indicate air quality problems can be investigated.

Exceptions:  None

Adoption:  Probable

MAS Comments:  This particular aspect caused much confusion in the USP <797> currently in effect.  We recommend that after a renovation or after new construction that tracking begin with 4 contiguous weeks of testing to establish a baseline for the collected data.

We also recommend that the pharmacy perform either quarterly or semi-annual third party testing to validate the in-house testing results.  MAS can supply all pumps, particle counters, agar plates and perform all types of pathogen and chemical air analysis.

MAS Comments

As stated above, some of the additions, revisions and changes listed here are not necessarily possible in all pharmacies.  Space limitations and the physical layout or geometry of the area where the CSP operations are performed may not always lend itself to a “perfectly designed” CSP area.  For the most part, as long as the intent to comply as much as is possible with USP <797> is attempted and that the actual air environment of the area where the CSP is taking place is within acceptable parameters, this may be adequate.  You state Board of Pharmacy may have published requirements that will assist in your design decisions.

MAS has worked with many pharmacies to ensure that our designs are economical and meet or exceed the USP <797> standard.  Our medical-grade laminar airflow units deliver ISO 5 or better clean air to both the Anteroom/Ante-area and the Buffer Zone.  There is no extra cost for this feature it is inherent in our equipment that this is provided.

It should be noted that having the Primary and Secondary Engineering Controls are not a substitute for proper procedures and protocols for the personnel performing the CSP.  The importance of having proper protective equipment (correct gloves, gowns, head coverings, shoe covering, etc.) and abiding by the Standard Operating Procedures (SOP) are paramount.  Most all contamination other than cross-contamination of drugs will usually come from the humans performing the CSP operation.  As an example, humans without protective garments generate the following:

Current Requirements

The following is taken from the present USP <797> standard.  USP stated that the FDA will retian the January 1, 2008 compliance date for these upgrades to take place. There are other non-engineering requirements that are not listed here.

        Buffer Zone parameters for this room are:

Laminar Air Flow Workstations (LAFW), Biological Safety Cabinets (BSC) and Compounding Aseptic Isolator (Glove Box)

1)      Should be placed in the Buffer Zone.  If they are countertop units, they need to be placed on a plain stainless steel table (no drawers or storage under the table).

2)      Positive pressure Primary Engineering Controls will utilize air from the Buffer Zone for the horizontal and/or vertical laminar flow air stream.

3)      Negative pressure barrier isolators for high risk CSP may import air from the Buffer Zone but this air cannot be recirculated back into the room, it must be vented to the outside.

Buffer Zone Laminar Flow Supply Air

1)      Must be provided through a minimum 99.97% HEPA filter.

2)      Must be provided from a ceiling laminar airflow diffuser.

3)      In virtually all cases the air should be provided by a fan-driven unit.  Most facility HVAC systems do not have the capacity to provide the volume of air needed through a HEPA filter for ACH and to maintain a constant positive pressure.

Buffer Zone Exhaust Air

1)      Exhaust air should be vented from the room via exhaust grilles that are located near the floor whenever possible.  In some cases this may not be practical and the exhausts will be in other areas of the room.

2)      Some or all air may be vented under the door into the Anteroom.

3)      Air from a negative pressure room or a negative pressure barrier isolator where high risk CSP is being performed must be vented to the outside.

Supplies

1)      Should not be stored in the Buffer Zone if at all possible.  As many flat surfaces as possible should be removed from the room.

2)      All supplies should be stored in the Anteroom or Ante-area.  All prep for drugs and personnel should be accomplished in this room.

3)      An Ante-area (separated by a curtain or demarcation line) is only acceptable if there is a low volume of low and medium risk CSP performed on an average day.

Horizontal Flat Surfaces

1)       All furniture and equipment not essential to the CSP operation should not be in the Buffer Zone.  It should be removed to outside the area.

2)       If there are horizontal flat surfaces that cannot be removed from the area then a procedure should be in place to clean these flat surfaces with biocidal type cleaning agent before each working day to prevent contamination of CSP elements.

3)       All surfaces should be able to withstand cleaning with biocidal type cleaning agents.  It is advisable that the compounding personnel do the actual cleaning of the CSP are to ensure sterile conditions.

Ceilings

1)      Should be a “clean room” type ceiling that is non-porous and gasketed with either “hold down” clips or other retaining devices for the ceiling tiles.  In some instances a sealed drywall ceiling can be used provided there are access hatches installed in the ceiling to access overhead laminar flow equipment.  Care should be taken to not have a ceiling in place that, under positive pressure, would lift ceiling tiles and allow contaminated air into the CSP area via the Venturi effect.

2)      A ceiling specifically designed for positive pressure room applications is recommended for this type room.  Simply using glue as a sealant in a standard drop ceiling is not sufficient.

3)      All ceiling equipment and fixtures (lighting, sprinkler heads, etc.) should be flush with the ceiling itself and withstand cleaning with a biocidal type cleaning agent.

4)      The ceiling, if installed as part of a renovation, must be sealed so that no air movement can occur between the working are and the interstice space above the room.

Walls

1)       Existing walls should have a non-porous surface or coating that can withstand cleaning with biocidal type cleaning agents. (An epoxy coating is ideal but other wall coverings can be used.)

2)       Walls that have to be created with wallboard (drywall) or prefabricated walls that can be erected in situ must also meet this requirement.

Floors

1)      Floors should be one contiguous covering with no cracks, crevices or seams where pathogen growth could occur including baseboards.

2)      If a tiled floor is existing then it should be removed and a contiguous floor installed or a heat sealed polymeric covering be installed over top of the existing tiled floor.

3)      All floor surfaces or coatings must be able to withstand cleaning with biocidal type cleaning agents.

4)      All baseboards should be sealed and must be able to withstand cleaning with biocidal type cleaning agents.

Airflow Dynamics (Air Mixing)

1)         Usually ignored by architects and engineers alike.  The placement of the air purification systems (APS) is critical in ensuring that the air that the LAFW’s and/or barrier isolators intake is pure, uncontaminated air, which, after passing through the workstation’s filter(s), makes it ultra-pure.

2)         Perfect air mixing is only possible when there are no mobile elements in a room.  A room designed for perfect air mixing will only be so until a person enters the room and disrupts the airflow pattern.  MAS has added upper room ultraviolet germicidal irradiation (UVGI) devices to ensure that the least risk of pathogen contamination can occur during the compounding operation.  This is not mentioned in USP <797>, but, it is an MAS value added option.

Anteroom and Ante-area parameters are actually the same as indicated above for Buffer Zones.  The only exception is for air changes and pressure.  Air changes and pressure are not defined in the current USP <797>.  .Air changes and pressure also are a non-issue when an Ante-area is in place.

In Conclusion

MAS will provide the finest state-of-art equipment specification data, design criteria (free at this time) with line drawings and written explanation, and an equipment quotation for your pharmacy.  We also have contractors nationwide that can provide you with an installation estimate upon your request.

Generally, a typical equipment quote (with no wall or roof penetrations) for 2 Primary Engineering units with all rooms enclosed will cost $18,000 ± $3,000.  This is for information purposes only and does not reflect what your actual equipment cost will or could be.

If you have any questions you can go to our web site and fill out the feedback form or send an e-mail to us.  For more immediate help call our corporate office at 800-645-1059,

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