ASTM E1567-93
(Guide)Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
SCOPE
1.1 This guide covers architectural design considerations for buildings and facilities used in the biological processing industry to make drugs, chemicals, and other products.
1.2 These designs are intended to meet current good manufacturing practices (cGMP) criteria and guidelines published by the U.S. Food and Drug Administration (FDA) for processes and products manufactured under CFR Title 21.
1.3 While the guidelines described are general in nature, they are not expected to apply to all of the possible biotechnical processes used in the industry today. Accordingly, the user of this guide must exercise good engineering judgment in specific design applications to select the proper guidelines that apply.
1.4 In addition to the cGMP guidelines provided herein, other regulations and guides should be considered that are promulgated by other federal agencies such as the Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), the U.S. Drug Administration (USDA), the National Institute of Health (NIH), and so forth.
1.5 While the buildings will be designed to meet specific functional requirements and comply with local zoning ordinances, building codes, handicapped employee standards, and so forth, these considerations are not included in this guide.
1.6 The values stated in SI units are to be regarded as the standard.
1.7 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E 1567 – 93
Standard Guide for
Biopharmaceutical Facilities Architectural Design
Considerations
This standard is issued under the fixed designation E 1567; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Other Document:
NIH Guidelines, Containment Area Designations
1.1 This guide covers architectural design considerations for
buildings and facilities used in the biological processing
3. Terminology
industry to make drugs, chemicals, and other products.
3.1 Definition:
1.2 These designs are intended to meet current good manu-
3.1.1 cGMP—abbreviation for current good manufacturing
facturing practices (cGMP) criteria and guidelines published
practices as defined in CFR Title 21, Parts 210 and 211.
by the U.S. Food and Drug Administration (FDA) for processes
and products manufactured under CFR Title 21.
4. Significance and Use
1.3 While the guidelines described are general in nature,
4.1 This guide is intended for use in designing laboratory,
they are not expected to apply to all of the possible biotechnical
pilot plant, commercial production buildings that will use
processes used in the industry today. Accordingly, the user of
processes involving living organisms to produce products.
this guide must exercise good engineering judgment in specific
These products are also manufactured under the FDA and other
design applications to select the proper guidelines that apply.
federal agency regulations.
1.4 In addition to the cGMP guidelines provided herein,
4.2 These guidelines include the layout of facilities, design
other regulations and guides should be considered that are
of containment areas, ventilation and air quality, personnel
promulgated by other federal agencies such as the Occupa-
areas, special processing hazards, controlled environment ar-
tional Safety and Health Administration (OSHA), the U.S.
eas, and other items.
Environmental Protection Agency (EPA), the U.S. Drug Ad-
4.3 This guide is for use by engineers, architects, and
ministration (USDA), the National Institute of Health (NIH),
owners of biopharmatechnical manufacturing facilities to con-
and so forth.
sider the special factors in laying out the facilities to meet
1.5 While the buildings will be designed to meet specific
cGMP requirements and other good engineering principles.
functional requirements and comply with local zoning ordi-
4.4 By using these guidelines along with other design
nances, building codes, handicapped employee standards, and
criteria required by a variety of regulatory agencies, a valida-
so forth, these considerations are not included in this guide.
tion effort can be achieved more easily to meet agency
1.6 The values stated in SI units are to be regarded as the
requirements and obtain operating permits.
standard.
4.5 This guide is intended to provide general guidelines for
1.7 This standard does not purport to address all of the
consideration and application in a variety of plant operations
safety problems, if any, associated with its use. It is the
and processes in which the designers can make specific
responsibility of the user of this standard to establish appro-
decisions concerning the exact architectural design features to
priate safety and health practices and determine the applica-
use.
bility of regulatory limitations prior to use.
5. Summary of Guide
2. Referenced Documents
5.1 This guide provides architectural design principles to
2.1 Code of Federal Regulations:
2 consider when applying federal regulations to biopharmatech-
CFR Title 21, Parts 58, 210, 211, 212, 606, 809, 820
nical plant facilities construction and functions. Check lists for
specific plant operation activity areas presented with criteria
1 for their design and layout considerations. Environmental
This guide is under the jurisdiction of ASTM Committee E-48 on Biotechnol-
ogy and is the direct responsibility of Subcommittee E48.01 on Materials for considerations are also included for aseptic and special laminar
Biotechnology.
Current edition approved Aug. 15, 1993. Published October 1993.
2 3
Available from Standardization Documents Order Desk, Bldg. 4, Section D, Available from National Institutes of Health, (NIH), 9000 Rockville Pike,
700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS. Bethesda, MD 20892.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1567
flow zones of operation. Fermenter area layout and space tion (see 21 CFR, part 212.3) to minimize contamination from
considerations are presented. When containment and closed air-borne particulates, including microorganisms. Personnel
area operations are necessary, the general criteria to be consid- entering the controlled environment area must use appropriate
ered by the designer is presented based on NIH Guidelines and non-linting garments inside it that are not to be used outside it,
good engineering practices. including in the changing area. This means that the design of
5.2 Plant layout considerations are included for all normal facilities will include a gowning area and garment storage areas
sections of a biotechnical operating plant. adjacent to the controlled environment area.
6.7.1 Gowning Area Design Considerations:
6. Guidelines
6.7.1.1 Sole means of personnel entry and exit, except for
6.1 First, establish which regulations apply to the specific
emergency exit.
project design. Review 21 CFR, Parts 210, 211, 212, and so
6.7.1.2 Located immediately adjacent to work areas.
forth; NIH Guidelines; and other specific information from
6.7.1.3 Equipped with containers for the disposal of used
federal agencies that applies to the functions intended in these
clothing and protective equipment.
facilities. For example, 21 CFR, Part 606, relates to cGMP for
6.7.1.4 Clean air supplied to the gowning area will have a
blood and blood components; Part 809 to in-vitro diagnostic
negative air pressure relative to the contained work area and
products for human use; Part 820 to medical devices; Part 58
positive air pressure relative to the adjacent non-controlled
to nonclinical laboratories; NIH guidelines to containment
areas. Differential pressures may be 1.3 to 3.8 mm water gage.
requirements, and so forth.
6.7.1.5 Provide hand washing facilities and warm-air drying
6.2 Adequate laboratory facilities must be provided for the
equipment within the gowning area similar to surgical room
testing of process intermediates and products (see section 21
washing facilities operated by foot or knee.
CFR, Part 211.22). The quality control function of the site
6.7.1.6 The gowning room should have a higher pressure
requires adequate laboratory space and facilities.
than the wash room and have loading changers to insert
6.3 Manufacturing employees must have education and
personnel clothing items into the room. Air showers and air
frequent training (see section 21 CFR, Part 211.25), which
locks should be considered.
requires training space or dedicated rooms for the cGMP
6.7.1.7 Finishes within the gowning room should be of the
training. This space can sometimes be combined with an eating
same quality as those in the controlled environment work area.
area or conference room.
6.7.1.8 The use of HEPA filters and ultraviolet lights should
6.4 Personnel must wear appropriate clothing and protective
be considered for garment lockers.
items (see 21 CFR, part 211.28), which implies storage area
6.7.1.9 Doors should remain closed when not in use; con-
lockers for clean and dirty work clothes and change lockers for
sider using automatic door closure and interlocks.
street clothes. Change rooms, laundry rooms, clothing staging
6.7.2 The air quality for controlled environment areas is
areas, and storage rooms may also apply.
described in 21 CFR, Parts 212.221 to 222. Consider the
6.5 Personnel sanitation and health activities require ad-
following:
equate wash rooms, showers, toilets, and storage areas for
6.7.2.1 Temperature Range—22 6 3°C.
supplies, according to Part 211.28.
6.7.2.2 Humidity Range—30 to 50 % relative humidity.
6.6 Building design and construction features in Part 211.42
6.7.2.3 Pressure Differential—0.05 in. (1.27 mm) of water,
require adequate space for the manufacturing, processing,
minimum, with all doors closed relative to the adjacent less
packing, or holding of a drug product. These areas include the
clean area.
following:
6.7.2.4 Sterility, HEPA Filtration—Not to exceed a particle
6.6.1 Receipt and identification of raw materials,
count (0.5 μm size) of 100 000/ft when measured with
6.6.2 Storage offtest and ontest raw materials,
automatic counters, or 700 particles of 5.0 μm size using a
6.6.3 Sample preparation and testing,
manual microscopic method. For sterile air over filling lines, a
6.6.4 In-process Materials—Ontest and offtest,
100 count is maximum for 0.5 μm particles at the point of use.
6.6.5 Manufacturing equipment,
6.7.2.5 Air Change Rate—20/h, minimum.
6.6.6 Equipment holding, cleaning, and staging,
6.7.3 Construction considerations must be designed to pre-
6.6.7 Packaging and labeling,
vent the physical facilities from becoming a source of particu-
6.6.8 Quarantine storage of finished products,
late contamination:
6.6.9 Utilities—Inert gases, steam generators, water for
6.7.3.1 Coating on all surfaces must resist deterioration and
injection (WFI), treated water, air (utility, clean, instrument,
flaking.
and sterile), and so forth,
6.7.3.2 Surfaces should be able to be cleaned effectively and
6.6.10 Sterilization Systems—Clean-in-place and sterilize-
easily.
in-place,
6.6.11 Waste treatment, 6.7.3.3 Smooth, hard surfaces clean best; use coatings such
as epoxy, cove bases flush with wall, covered corners, sealed
6.6.12 Offices, personnel change rooms, and containment
access areas, and joints, flush fitting doors and windows, wall protection, and
corner guards.
6.6.13 Control room, quality assurance and quality control
areas, and so forth. 6.7.3.4 Conceal all ducts, conduits, piping, etc. above ceil-
6.7 The controlled environment area must be environmen- ings and behind walls. Exposed pipe and conduits for equip-
tally controlled, with special air quality, lighting, and construc- ment connections should be installed vertically.
E 1567
TABLE 2 Physical Containment Requirements
6.7.3.5 Install insect control units and screens on vents and
openings, as appropriate. BSL1-LS BSL2-LS BSL3-LS
6.7.3.6 Separate underslab piping from the controlled envi-
Emergency plans for handling large losses X X X
Must use a closed system X X X
ronment areas.
Add materials, sampling in a closed system X X X
6.8 Containment Area Designations from NIH:
Inactivate cultures usi
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