IFMA San Diego Intro to Life Sciences Facility Design

IFMA San Diego

Intro to Life Sciences Facility DesignPresentation by Nancy Escano AIA, Managing Principal, DGA March 2009

IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 2

I. Intro to Life Sciences Facility Design

II. Codes and Regulations

III. Optimizing Existing Facilities

Topics Covered in Today’s Presentation

I. Intro to Life SciencesFacility Design


Public – Designed for Research and Discovery

• Generic labs – standardized for multiple research applications

• Denser labs with a high ratio of personnel per square foot of lab space

• Scientific offices in or directly adjacent to the labs

• Separate teams devoted to research in multiple fields

Private – Research Aimed at Product Development

• Lab design tailored to a specific area of research

• More generous ratio of personnel to square footage of lab space – to attract and retain the brightest and the best

• Scientific offices adjacent to or located away from research environment

• All researchers collaborate towards a common goal or goals

Public vs. Private Laboratories


DrugA compound or substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in people or animals.

How Does a Drug Work?

• By reinforcing natural body substances

• By blocking natural body substances

What is a Drug?


Phase One

• Is it safe in healthy humans? What is the dosage?

Phase Two

• Is it safe in ill humans? Will it work?

Phase Three

• Does it achieve the desired result?

Phase Four

• Post-launch marketing evaluation

• Extend the range of conditions

Clinical Trials


Understand the Company’s Product Evolution• Research, development, clinical, product launch

Understand the Company’s Product Type• Drug discovery, drug delivery, medical device, bio fuel

Understand the Company’s Structure• Core functions vs. project teams

Understanding the Company


Product Types

Drug Discovery• Pharmaceuticals: Chemical drug compound

• Synthesis: Artificially produced life form

• Biotech: Modification of life forms

Drug Delivery• Solid Dose: Tablet

• Parenteral: Injection

• Inhalation: Powder or liquid inhaled

• Transdermal: Absorbed through the skin

• Topical: Non-absorbing

Medical Device• Invivo: Implanted device

• Invitro: Non-life-critical devices


Research

• High ratio of lab to office

• Basic laboratories – chemistry & biology

• Support or specialty labs – tissue culture, NMR

Development

• Ratio of lab of office shifts

• Addition of vivarium and /or scale-up labs

Clinical Manufacturing

• Ratio of lab to office similar to development

• Addition of a pilot plant and CA/CC/Regulatory

Commercial Manufacturing

• Typically a separate facility

Typically, it takes about 10 years for an idea to become a product.

Company Development


Drug Discovery 325 to 400 sf per person

Bio Fuel 300 to 400 sf per person

Drug Delivery 300 to 375 sf per person

Medical Device 200 to 350 sf per person

Genomic/Gene Chip 350 to 425 sf per person

Institutional/Educational 300 to 650 sf per person

Benchmarking

The ratio of lab to office shifts as a company matures. Incubator/start-up companies can be 70/30 lab-to-office ratio. As the company moves into clinical trials it shifts to 40/60 lab-to-office ratio.


Biology

Lab Types: Molecular Biology, Microbiology, Biochemistry,Cell Biology

Critical Adjacencies: General Laboratory to Support Spaces most critical

Support Spaces: Tissue Culture, Cold Room, Dark Room, Radioactives Lab, Liquid Nitrogen Storage/Freezers, Common Equipment (freezers, centrifuges), Microscopy

Chemistry

Lab Types: Organic, Synthetic, Synthesis, Analytical, Peptide

Critical Adjacencies: General Laboratory to Office Spaces

Support Spaces: NMR, Lyophilizers, Cold Room, Mass Spec, HPLC, Chemical Weigh Room, Chemical Storage, Common Equipment (freezers)

Lab Types


Analytical Chemistry

Lab Types: Analytical Chemistry, ADME (Absorption, Distribution, Metabolism and Excretion), Pharmacology, Quality Control

Critical Adjacencies: General Laboratory to Office Spaces

Support Spaces: Common equipment (freezers), Cold Room

Robotics Labs

Lab Types: High Throughput Screening (HTS)

Critical Adjacencies: Compound Storage

Support Spaces: Compound Storage

Lab Types


Fermentation

Lab Types: Fermentation, Cell Culture

Critical Adjacencies: Purification, Utility Room

Support Spaces: Media Prep, Wash-Autoclave Room

Pharmacology

Lab Types: Histology, Necropsy, Toxicology, Metabolism, Pharmacokinetics, Immuno-Histo Chemistry, Insitu

Critical Adjacencies: General laboratory to animal facility

Support Spaces: Similar to Biology

Lab Types


Scientists typically want a close proximity between their lab and office space as there is lots of back and forth between those areas.

Given the choice of being directly adjacent to lab support or offices, typically:

• CHEMISTS prefer a direct adjacency to their offices as they are moving often between the lab bench and their desk

• BIOLOGISTS prefer a direct adjacency to their support spaces as they often move samples from the lab bench to the support space

Lab | Office | Lab Support


• Placement of benches allows natural light to penetrate deep into the lab interior

• Low-flow hoods where jurisdictions allow; otherwise consider combination sashes

• Self-closing or motion-sensor water fixtures

• Material and finish selections

• Movable casework and carts

• Metal casework has higher recycled content than wood

• Solid phenolic or plastic laminate countertops eliminate the demand for petroleum-based epoxy countertops

Carbon Footprint / LEED

PENETRATING SUNLIGHT


• Labs21® is a voluntary partnership programdedicated to improving the environmental performance of U.S. laboratories

• Offers professionals an opportunity for information exchange and education

• Co-sponsored by the EPA and the DOE

• International Institute for Sustainable Laboratories (I2SL) in partnership with Labs21 offers training courses in laboratory design and O&M

Labs for the 21st Century


FUME HOODChemical Hood is designed to protect the user. Air flow is across the work surface and out the back of the hood. It is always exhausted.

Fume Hood, Biohood, Whatever

BIOSAFETY CABINET/HOODA Biosafety cabinet (biohood) is designed to protect the product and sometimes also the user. The air flow depends on the hood type. Some biohoods are fully exhausted, some partially exhausted and some are fully re-circulated. This discharge of a biohood is HEPA filtered.

II. Codes & Regulations


• Labs are a “B” occupancy

• 4 Control Areas per building

• No limitation on locations in the building

• One-hour fire separation – floors and walls regardless of location

• Existing per Chapter 10 general requirements

• Set exempt amount for Health Hazards and Physical Hazards

• Once the Control Area limitation is exceeded, alternative is to provide “H” Occupancy

Control Areas: CBC 2001


Current CBC:

• Number of Control Areas and the Haz Mat exempt amount depends on the location in the building

• Fire-separation requirements – depend on the location in the building

Control Areas: CBC 2007


• Number of suites per floor:– 2007 – limited to 10– 2009 – NO LIMIT– 2010/2011 – Major revisions under way – number

of suites will be limited as related to height and maximum amount for certain chemicals

• 10,000 s.f. maximum per Lab Suite• Horizontal Exit – required above the 3rd Floor• Exempt amount of Hazardous Materials

– Floors 1 through 3 – 100%– Floors 4 through 6 – 75%– Floors 7 and above – 50%

• Emergency power required for ventilation, temp control, fire alarm, and required elec system, treatment systems, egress lights

• Exit doors from the suites need panic hardware

“L” Occupancy: CBC 2007


• 2 exits required for Lab Suite over 500 s.f.• 2-hour separation from “B” occupancy control areas• Special ventilation requirements

– Independent exhaust duct per Lab Suite, or provide sub-duct design– Exhaust cannot penetrate the 2-hour fire barrier– Minimum 6 air changes per hour or 1 cfm per s.f. – During emergency condition, maintain required door opening force and sustain a

differential pressure negative to surrounding area• Liquid-tight floor• Higher-density sprinkler system• Requires 50 s.f. dedicated emergency

response equipment area per floor

“L” Occupancy: CBC 2007


• All laboratory space should be accessible to the wheelchair-bound

• Some companies have reduced all bench heights to 34” and installed shallow sinks, but this is problematic:

– 34” height benches uncomfortable for the able-bodied

– Shallow sinks are not functional for a researcher whether able-bodied or wheelchair-bound

– Low counters do not guarantee that a wheelchair-bound person can perform work in the labs as some equipment is top-loading

• Consider an agreement with the building officialthat you will:

– Modify specific workstations for disabled employees when hired

– Purchase an adjustable wheelchair

Accessibility


Level One

Also referred to as: BL1, BSL1 or P1

• The laboratory is designed so that it can be easily cleaned

• Bench tops are impervious to water and resistant to acids, alkalis, organic solvents and moderate heat

• Laboratory furniture is sturdy. Spaces between benches, cabinets and equipment are accessible for cleaning

• Each laboratory contains a sink for hand washing

• If the laboratory has windows that open, they are fitted with fly screens.

Level Two


• Same criteria as above

• An autoclave for decontaminating infectious laboratory waste is available

Biosafety Levels


Level Three


• Airlock/gowning room entrance off access corridors. Double-door access

• Interior surfaces of walls, floors and ceilings are easily cleaned. Penetrations are sealed

• Bench tops impervious to water and resistant to acids, alkalis, solvents and heat

• Laboratory furniture is sturdy and spaces between are accessible for cleaning

• Hand-washing sink is hands-free or automatically operated near the exit door

• Windows in the lab are closed and sealed

• Access doors are self-closing

• An autoclave is available, preferably within the laboratory

• A ducted exhaust air ventilation system is provided. No return air. Negative pressure must be verifiable. The room does not require filter on the exhaust

• HEPA-filtered exhaust air for Class I or Class II biosafety cabinets discharged directly to the outside

Biosafety Levels


This safety equipment is an OSHA requirement. Equipment can be individual units or a combination unit. Important points to remember include:

• Emergency eyewash/showers must be withina 10-second travel distance from the point of need (assume approximately 60’)

• The shower head flow has been designed assuminga mounting height of 8’

• This equipment is tested monthly – they use a shower curtain and a large trash can

• We do not recommend installing a drain at an emergency shower

• Emergency equipment must be accessible to the disabled

Emergency Eyewash & Showers

III. Optimizing Existing Facilities


• Create solutions that will support departmental growth until expansion space is available

• Minimize disruption to operation

• Involve the users in solution development and the decision-making process

Optimization Study


Optimization Study – Process

PROGRAMMING:Program Interview

Generate Customer Profiles

User Review Customer Profiles

Room Interviews

Prepare Programming

Deliverable

User Review of Program

Spring Cleaning

OPTION DEVELOPMENT:

Room SurveyOption

DevelopmentUser Review of Options

Prepare Option

Deliverable

Legend

Final Option Selection

User Involvement

Steering Committee Involvement

Design Team Effort


Optimization Study


Optimization Study


• “Clean your room!”

• Manage prep bench assignments

• Maximize equipment bench

• Study travel distances

• Manage supply storage/“stuff space”

• Consider multi-use support “spaces

• Re-purpose spaces

Lab Optimization / Compression


• Boom boxes off the bench/couches out of the lab

• Evaluate freezer storage on a regular basis

• Spring cleaning

Obsolete equipment will be tagged in one of the following 3 categories:

TRASH: Definitely not usable

WAREHOUSE: Placed in a quarantine area/off-site storage

RECYCLE: Other groups in the company may want to claim

• Throw out supplies that have expired

“Clean Your Room!”


Traditional Bench Assignments

• Personal prep bench, 6’ to 8’ per person

• Additional bench for shared equipment setups

• Optimize by decreasing length per person(can be challenging because of knee spaces)and do not allow multiple prep stations per person

Shared Prep Bench Assignments

• Prep bench assigned by function, not by person

• No personal bench assignments

• Optimize by scheduling

Manage Prep Bench Assignments


• Store periodic-use equipment

• Eliminate obsolete equipment

• Think 3-dimensionally – knee spaces, racking, and upper shelves

• Rack and stack computers – monitor arms,keyboard trays and towers in knee spaces

• Custom casework solutions

- Heavy-duty pull-out shelves

- Analytical equipment carts

Maximize Equipment Bench


Study Travel Distances

Assay #1 – 175’Assay #2 – 55’Assay #3 – 220’Assay #4 – 280’Assay #5 – 305’Assay #6 – 315’


• “Just-in-time” supplies to free storage areas for other functions

• Don’t use the bench for storage

• High-density supply storage

Manage Supply Storage / “Stuff Space”


• What is the Metric?

– Area per person

– Linear bench per person

– Throughput

• How does your utilization compare to the industry?

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Lab Capacity


• Once the metric is determined, capacity can be calculated

• Most companies track lab use as square foot per person

• For simplicity, some companies decide on a standard multiplier if the utilization per department is similar

Initial RecommendationLab SF Deficit Area Total Staff Lab sf/pers Rec/multiplier

Biology 6,754 17 397 320Chemistry 9,687 30 323 350Bioanalytical 8,153 29 281 320Pre-Formulation 4,827 1,200 20 301 320Pharm Dev 4,564 22 207 250Analytical 8,490 35 243 250

Final DecisionLab SF Deficit Area Total Staff Lab sf/pers Rec/multiplier

Biology 6,754 17 397 320Chemistry 9,687 30 323 320Bioanalytical 8,153 29 281 320Pre-Formulation 4,827 1,200 20 301 320Pharm Dev 4,564 22 207 320Analytical 8,490 35 243 320

Lab Capacity


The lab diagram shown is a 30’ lab bay.

Lab Bay A: 51’-8”Lab Bay B: 53’-0”

Average Lab Bay = 52’-4”3 People/Lab Bay = 17’/ person2.5 People/Lab Bay = 21’/person

By Cost Center SSF VV SD Por Total LU/Per NSF/Per GSF/Per Linear Use Net SF Gross SF

QC Bioassay** 28 7 10 45 33 241 428 1,467 10,861 19,264QC Stability 28 28 22 133 225 604 3,713 6,293Raw Materials 35 24 5 64 20 124 202 1,300 7,957 12,953Environmental QC 32 26 8 5 71 21 140 277 1,512 9,975 19,660In-Process Testing 35 44 8 4 91 21 140 255 1,918 12,708 23,192Reference Materials 91 625 1,108Marketed Products 41 8 24 73 20 124 211 1,493 9,043 15,427Microbiology** 23 23 8 5 59 29 183 337 1,723 10,807 19,911Validation 5 5 17 113 191 85 564 956Analytical Technology 63 20 83 21 131 233 1,784 10,900 19,363Biological Technology 18 18 20 148 272 356 2,656 4,887Quality Support 4 4 1,192 8,438 15,261Totals 308 108 102 23 541 85,368 150,657

Per Person TotalCurrent Blended

• Some companies track lab capacity by linear use of bench or lab

Capacity Analysis – Linear Usable


Building Selection Criteria

• Floor Loading is ideally 125 to 150 live load. Lesser structural capacity will work; however, there is less flexibility

• Floor to Floor of 16’ to 17’ is optimum. Lower and higher height can work but it typically requires more coordination and often more cost

• Column Bay Space in increments of 10’ or 11’ in at least one direction is preferred

• Building Shape that is rectangular offers more opportunity for windows. Square buildings are good for pilot plants and vivaria if located on a first floor

• Multi-tenant Buildings have unique challenges. It’s better if the loading dock is centrally located. Control areas should be assigned to tenants in the lease

• Service Yard area in the parking lot is important.• Utility Capacity should be adequate for the use.

This includes water, power, waste and gas

Ideal Lab Building

Thank You

IFMA San Diego

Intro to Life Sciences Facility DesignPresentation by Nancy Escano AIA, Managing Principal, DGA March 2009

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IFMA San Diego Intro to Life Sciences Facility Design

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