Element Z General Design Requirements Room Standards

Transcription

1 Pharmaceutical 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 (Owner). B. Refer to the D series Owner s Design Guideline Elements for requirements relating to mechanical, plumbing, and electrical work. Refer to Element D 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. 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. ODG OF 7

2 Pharmaceutical 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 ODG OF 7

3 Pharmaceutical 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. ODG OF 7

4 Pharmaceutical 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 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 poweroperated, 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. ODG OF 7

5 Pharmaceutical 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 AIR DISTRIBUTION REQUIREMENTS A. Refer to Owner s Design Guideline Element D 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. Ceilingmounted 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. ODG OF 7

6 Pharmaceutical 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 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. ODG OF 7

7 Pharmaceutical 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: B. For renovation projects, refer to Owner s Master Construction Specifications. These are available on the Owner s Design Guidelines website: PART 5 - DOCUMENT REVISION HISTORY Issue Date Revision Description Reviser Initial Adoption of Element Rev. 1 Rev. 2 Rev. 3 Rev. 4 Rev. 5 END OF ELEMENT ODG OF 7