Element Z General Design Requirements

Room Standards
Z4075 Pharmaceutical
Compounding Rooms

PART 1 - GENERAL
1.01 OVERVIEW

A. This document provides design and construction criteria for rooms/suites used for the
compounding of non-hazardous and hazardous pharmaceuticals at The University of Texas
MD Anderson Cancer Center (Owner).

B. Refer to the “D” series Owner’s Design Guideline Elements for requirements relating to
mechanical, plumbing, and electrical work. Refer to Element D304104 for mechanical
requirements specific to pharmaceutical air handling distribution.

C. Design shall be in accordance with The United States Pharmacopeia and The National
Formulary (USP-NF) latest Edition, and General Chapters <797>, Pharmaceutical
Compounding- Sterile Preparations (CSP) and <800>, Hazardous Drugs - Handling in
Healthcare Settings.

D. Design shall be in accordance with requirements of the following:

1. Texas State Board of Pharmacy.

2. The Facility Guidelines Institute, Guidelines for Design and Construction of Healthcare
Facilities.

3. International Standards Organization, ISO Clean Room Standards.

4. Code of Federal Regulations, Title 21, Part 211, Chapter 1, Subpart C, Sections 42, 44,
46, 48, and 52.

PART 2 - DESIGN CRITERIA

2.01 GENERAL

A. Basic design for the compounding space shall consist of an ISO Class 5 Primary Engineering
Control (PEC) located within an ISO Class 7 Buffer, IV, or Chemo room. Access to these
rooms shall be through an ISO Class 7 Anteroom.

B. Design shall allow a High Risk Level of compounding to be performed.

C. Provision for an airlock (in addition to an Anteroom) may need to be made, depending on
volume of compounding to be done.

D. The PEC function is typically satisfied through the use of a five (5) foot or six (6) foot Class II
B2 biological safety cabinet (BSC) where non-hazardous and hazardous compounds are
involved. Use of another type PEC, such as a laminar airflow work station, requires approval
of Owner’s Project Manager.

1. Provide a closure panel between the top of PECs and the ceiling.

2. PECs shall be located out of traffic patterns and away from circulating air currents.

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 1 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
3. The following minimum clearances shall be provided around individual BSCs:

a. Forty (40) inches by the full length of BSC, as work space, in front.

b. Twelve (12) inches to nearest side wall or column.

c. Eighty (80) inches to opposing wall.

d. Five (5) feet to opposing bench tops or areas of occasional traffic.

e. Forty (40) inches to bench tops at perpendicular walls.

4. Where rooms contain multiple BSCs, a staggered design arrangement is preferred. If

offsetting of BSCs cannot be accomplished, the following minimum clearances shall be
provided at the BSCs:

a. Ten (10) feet, when facing each other.

b. Forty (40) inches, when located next to each other along the same wall.

c. Four (4) feet (in both directions), when located along perpendicular walls.

5. BSCs shall not be located near entry doors. If locating BSCs a substantial distance from
in-use doors is not possible, a minimum distance of forty (40) inches at the side and five
(5) feet at the front of the BSC to the nearest door jamb shall be provided.

E. The following pressure relationships shall be maintained:

1. Non-hazardous clean (Buffer and IV) rooms: 0.01-inch to 0.03-inch positive air pressure
with respect to their anterooms, with an operational design objective of 0.02-inch air
pressure.

2. Hazardous clean (Chemo) rooms: 0.01-inch to 0.03-inch minimum negative air pressure
with respect to their anterooms, with an operational design objective of 0.02-inch air
pressure.

3. Anterooms: 0.02-inch minimum positive air pressure with respect to adjoining

circulation/workroom spaces.

4. Pressure gauges shall be provided to continuously monitor the differential air pressure
between the compounding rooms, Anteroom, and general environment outside the
compounding area.

F. Design conditions for Buffer, IV, and Chemo rooms shall be sixty eight (68) degrees
Fahrenheit and fifty (50) – sixty (60) percent relative humidity.

G. Where swing type doors are provided, doors at negative pressure hazardous clean (Chemo)
rooms shall swing into the room, and doors at positive pressure non-hazardous clean (Buffer
and IV) rooms and Anterooms shall swing outward from the space.

H. Non-hazardous and hazardous clean rooms and Anterooms shall be designed for thirty (30)
air changes/hour. If recirculating BSC(s) are used, they may provide up to fifteen (15) of the

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 2 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
total air changes/hour required in a room. BSC(s) shall not provide the sole means of exhaust
in a space.

I. A storage area separate from compounding rooms shall be provided for storage of selected
hazardous pharmaceuticals. The space shall be designed with negative air pressure with
respect to adjacent spaces, and with twelve (12) air changes/hour.

J. Anteroom:

1. Provide a hands-free hand washing sink of adequate dimensions to allow for washing up
to the elbow. Hot and cold water volume shall be adjustable, with hot water provided at a
consistent one hundred (100) degrees Fahrenheit maximum. Locate the sink near the
entry door when possible.

2. An eyewash located at the sink or an eyewash station shall be provided.

3. A bench and storage facilities for personnel garbing shall be provided.

4. Two distinct colors shall be provided at the floor to form a demarcation line between
“clean” and “dirty” areas of the space.

5. A rectilinear footprint, without offsets, is preferred for its relative design advantage in
achieving uniformity of air flow.

6. Space for package handling and storage shall be provided unless separate rooms are
provided for these functions.

K. Separate “clean” and “dirty” store rooms, receiving/break-down room, pump room,
housekeeping, and workroom support areas shall typically be provided. These spaces are
typically located outside the ISO Class 7 environment; however, requirements shall be
confirmed with Owner’s Project Manager and the Facility Program.

1. The receiving/break-down room shall comply with USP-NF Chapter <800>.

2. The pump room shall contain shelving for storage of miscellaneous items, as well as
shelves for use in charging equipment. Provide a quantity of charging shelves and
associated duplex electrical outlets based on equipment needs and requirements of the
Facility Program, but not less than four (4) shelves, each with six (6) duplex outlets.

3. Space for a large container for dirty personal protective equipment shall be provided in
the receiving/break-down room or dirty-storage room, if provided.

L. The rooms/suites shall be designed to operate twenty four (24) hours/day, seven (7)
days/week.

M. Compounding rooms and associated Anterooms shall have a redundant (N+1) air handling
unit source connected to a common air distribution system and building automation system
(BAS) controls. This requirement may be modified to suit the Facility Program, which will be
developed with participation by Pharmacy representatives, and confirmed by the Owner’s
Project Manager.

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 3 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
1. Provide a minimum of two BSCs in each compounding room. Overall design shall enable
one or more BSCs to remain in use should the other(s) become inoperable.

N. Provide emergency power, where available, to storage spaces and equipment as required to
maintain proper temperature and humidity of critical pharmaceuticals. Confirm requirements
with the Facility Program.

2.02 ARCHITECTURAL REQUIREMENTS

A. Non-hazardous and hazardous clean rooms (Buffer, IV, Chemo) and Anterooms:

1. Walls: Gypsum board with epoxy paint finish. Provide integral cove trim (with
approximately one inch radius) at intersection with the ceiling and at inside corners of
walls.

2. Ceiling: Suspended, epoxy painted gypsum board. Provide gasketed access doors, as
required, for all above-ceiling items requiring access.

3. Floor: Seamless sheet vinyl flooring with heat welded seams and smooth surface. Avoid
flooring with hard-to-clean textured surfaces.

4. Base: Coved (radiused), seamless sheet vinyl integral with floor finish and flush with wall
surface. Use of projecting trim at top of base is to be avoided.

5. Light fixtures shall be designed specifically for clean room application. Light fixtures shall
be flush with the surface of the ceiling and have smooth lenses. Fixture perimeter and
any openings shall be sealed.

1) Provide emergency power, where available, to selected light fixtures at

spaces/equipment storing critical pharmaceuticals. Confirm requirements with
the Facility Program.

6. All fixed work surfaces shall be stainless steel.

7. Buffer, IV, and Chemo rooms shall not contain sinks or floor drains.

8. Acoustical design for noise from building systems shall be NC 40, maximum.

9. Doors shall be forty two (42) inches wide with a vision panel, and have stainless steel
hardware.

a. Doors between the Anteroom and Chemo, IV, and Buffer room(s) shall be power-
operated, provided with emergency power, and be activated by a touch-free “hand
wave” type sensor.

1) Aluminum sliding glass doors with seals/gaskets appropriate for maintaining air
pressure differentials shall typically be provided.

2) Use of fiberglass swing doors may be considered in lieu of sliding type doors if it
can be confirmed that the design (room shape, door separation, air device
placement, etc.) will allow the room(s) to maintain proper air
segregation/pressure differentials when doors are opened and closed.

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 4 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
b. Doors to Anterooms shall be designed to interlock such that no two doors in the room
can be open at the same time.

10. Provide windows set in stainless steel frames in the rooms for vision between each other,
and from the adjacent work/support spaces.

B. Typically provide pass-through chambers to minimize the need for movement between
working areas and Chemo, IV, and Buffer rooms. Chambers shall be a minimum of eighteen
(18) inches by eighteen (18) inches by eighteen (18) inches in size and have double
interlocked doors to maintain air pressure differentials.

2.03 AIR DISTRIBUTION REQUIREMENTS

A. Refer to Owner’s Design Guideline Element D304104 for additional information/requirements.

B. HEPA filters are to be located at ceiling level, and installed with provisions to facilitate testing
and recertification from inside the room. Provide gasketed ceiling access doors as required.

C. Air distribution grilles at non-hazardous and hazardous clean rooms (Buffer, IV, Chemo) and
Anterooms:

1. Locate HEPA-filtered supply air grilles and return/exhaust grilles so as to avoid the
formation of areas of relatively low, or no air movement within the room, and to create a
general top-down dilution of the area air. Typically, locating supply air at the ceiling and
return/exhaust air at walls six (6) inches from the floor, with adequate dispersion of the
various types of devices around the room, is required to achieve this goal. Ceiling-
mounted return/exhaust air devices shall not be used.

a. Downward, unidirectional air flow for supply air is preferred, provided an overall
laminar flow design, without turbulence, can be achieved.

b. Supply air grilles shall not be located directly over, or at the front of BSCs.

2. Proper laminar, uniform air circulation within the room shall be confirmed through a
smoke visualization testing method prior to Substantial Completion.

D. Where a BSC is exhausted to the exterior, the fan shall be dedicated and provided with
emergency power.

E. Differential air pressure, temperature, and humidity of non-hazardous and hazardous clean
rooms (Buffer, IV, Chemo) and Anterooms shall be monitored through tie-in to the BAS.
Status displays shall be located outside the entrance door to each room.

F. Provide an exhaust adjacent to the compressor for each refrigerator located in a negative
pressure clean (Chemo) room.

G. Air flow at BSCs shall be monitored through tie-in to the BAS.

H. Low-mounted exhaust and return air grilles shall be installed in rooms with PECs to allow for
functionality in the event a BSC becomes inoperable.

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 5 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
2.04 SECURITY

A. Access to the Pharmacy suite, which includes compounding areas and their support spaces,
shall be through secured doors with keyed entry and card access control hardware.

B. Provide video coverage at locations where pharmaceuticals are mixed, dispensed, and
distributed, and at locations approved by the Owner’s Project Manager and UTPD. Refer to
Owners Design Guideline Element D5038 for additional information.

2.05 EQUIPMENT AND FURNISHINGS

A. Provide standard refrigerators, ultra-low refrigerators, rolling shelving units, and movable
work stations as required by the Facility Program.

1. All refrigerators and freezers shall be provided with emergency power and be monitored
through the BAS.

2. Additional equipment, such as BSCs may be provided with emergency power depending
on Facility Program requirements.

B. All carts, shelving, movable work stations, and similar items within non-hazardous and
hazardous clean rooms (Buffer, IV, Chemo) and Anterooms shall be provided with casters.

C. Automated systems to be supported include Cato, Pyxis, and Barcode scanning for inventory
receipt.

1. Provide data connections and electrical power to equipment as required by the Facility
Program.

2. Pyxis equipment shall be provided with emergency power.

D. The status board requirement is to be satisfied through use of large-format televisions

mounted to the walls.

E. Trash bins, when provided, shall have lids.

F. All surfaces of fixtures, shelving, casters, and cabinets/work stations, etc. shall be smooth,
impervious, and without cracks, crevices or other design which would make cleaning and
disinfecting difficult.

PART 3 - SPECIAL CONTRACT DOCUMENT REQUIREMENTS

3.01 GENERAL

A. Obtain approval from Owner’s Project Manager/Planner Designer for all finish schedules prior
to issuance of Construction Documents.

B. All finishes should reflect the standard finish application for the specific building in which the
pharmaceutical compounding rooms and support spaces are located.

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 6 OF 7
 Element Z General Design Requirements
Room Standards
Z4075 Pharmaceutical
Compounding Rooms
C. Include general notes which require testing of components and systems for proper
functioning at the earliest opportunity during construction, and prior to any testing required to
attain Substantial Completion. Smoke visualization testing shall be conducted at intervals,
when practical, and shall be observed by Owner, at its option.

PART 4 - PRODUCTS
4.01 GENERAL

A. For all projects (renovation and new), refer to Owner’s Interior Finishes Standards. These are
available on the Owner’s Design Guidelines website:
http://www2.mdanderson.org/depts/cpm/standards/interiors.html

B. For renovation projects, refer to Owner’s Master Construction Specifications. These are
available on the Owner’s Design Guidelines website:
http://www2.mdanderson.org/depts/cpm/standards/specs.html

PART 5 - DOCUMENT REVISION HISTORY

Issue Date Revision Description Reviser

10-21-15 Initial Adoption of Element
Rev. 1
Rev. 2
Rev. 3
Rev. 4
Rev. 5

END OF ELEMENT Z4075

The University of Texas PHARMACEUTICAL COMPOUNDING ROOMS

MD Anderson Cancer Center Z4075
ODG102115 7 OF 7