Intro to Life Sciences Facility Design

Transcription

1 IFMA San Diego Intro to Life Sciences Facility Design Presentation by Nancy Escano AIA, Managing Principal, DGA March 2009

2 Topics Covered in Today s Presentation I. Intro to Life Sciences Facility Design II. Codes and Regulations III. Optimizing Existing Facilities IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 2

3 I. Intro to Life Sciences Facility Design

4 Public vs. Private Laboratories 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 4

5 What is a Drug? Drug A 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 5

6 Clinical Trials 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 6

7 Understanding the Company 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 7

8 Product Types Drug Discovery Pharmaceuticals: Synthesis: Biotech: Chemical drug compound Artificially produced life form Modification of life forms Drug Delivery Solid Dose: Parenteral: Inhalation: Transdermal: Topical: Tablet Injection Powder or liquid inhaled Absorbed through the skin Non-absorbing Medical Device Invivo: Invitro: Implanted device Non-life-critical devices IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 8

9 Company Development 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. IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 9

10 Benchmarking Drug Discovery Bio Fuel Drug Delivery Medical Device Genomic/Gene Chip Institutional/Educational 325 to 400 sf per person 300 to 400 sf per person 300 to 375 sf per person 200 to 350 sf per person 350 to 425 sf per person 300 to 650 sf per person 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. IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 10

11 Lab Types 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) IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 11

12 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 12

13 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 13

14 Lab Office Lab Support 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 14

15 Carbon Footprint / LEED 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 PENETRATING SUNLIGHT 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 15

16 Labs for the 21st Century Labs21 is a voluntary partnership program dedicated 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 16

17 Fume Hood, Biohood, Whatever FUME HOOD Chemical 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. BIOSAFETY CABINET/HOOD A 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. IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 17

18 II. Codes & Regulations

19 Control Areas: CBC 2001 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 19

20 Control Areas: CBC 2007 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 20

21 L Occupancy: CBC 2007 Number of suites per floor: 2007 limited to 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 21

22 L Occupancy: CBC 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 22

23 Accessibility 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 wheelchairbound person can perform work in the labs as some equipment is top-loading Consider an agreement with the building official that you will: Modify specific workstations for disabled employees when hired Purchase an adjustable wheelchair IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 23

24 Biosafety Levels 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 Also referred to as: BL2, BSL2 or P2 Same criteria as above An autoclave for decontaminating infectious laboratory waste is available IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 24

25 Biosafety Levels Level Three Also referred to as: BL3, BSL3 or P3 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 25

26 Emergency Eyewash & Showers 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 within a 10-second travel distance from the point of need (assume approximately 60 ) The shower head flow has been designed assuming a 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 26

27 III. Optimizing Existing Facilities

28 Optimization Study 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 28

29 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 Survey Option Development User Review of Options Prepare Option Deliverable Final Option Legend Selection User Involvement Steering Committee Involvement Design Team Effort IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 29

30 Optimization Study IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 30

31 Optimization Study IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 31

32 Lab Optimization / Compression 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 32

33 Clean Your Room! 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 33

34 Manage Prep Bench Assignments 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 34

35 Maximize Equipment Bench 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 35

36 Study Travel Distances Assay #1 175 Assay #2 55 Assay #3 220 Assay #4 280 Assay #5 305 Assay #6 315 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 36

37 Manage Supply Storage / Stuff Space Just-in-time supplies to free storage areas for other functions Don t use the bench for storage High-density supply storage IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 37

38 What is the Metric? Area per person Linear bench per person Throughput How does your utilization compare to the industry? % % 80% 70% % 50% 40% % 20% 10% 0% A-Life Science B- Life Science C - Life Science D - Life Science E - Electronics F - Microelect. G - Life Science H - Life Science IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 38 Gross SF per Person Lab Capacity

39 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 Recommendation Lab SF Deficit Area Total Staff Lab sf/pers Rec/multiplier Biology 6, Chemistry 9, Bioanalytical 8, Pre-Formulation 4,827 1, Pharm Dev 4, Analytical 8, Final Decision Lab SF Deficit Area Total Staff Lab sf/pers Rec/multiplier Biology 6, Chemistry 9, Bioanalytical 8, Pre-Formulation 4,827 1, Pharm Dev 4, Analytical 8, IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 39

40 Capacity Analysis Linear Usable The lab diagram shown is a 30 lab bay. Lab Bay A: 51-8 Lab Bay B: 53-0 Some companies track lab capacity by linear use of bench or lab Average Lab Bay = People/Lab Bay = 17 / person 2.5 People/Lab Bay = 21 /person Current Blended Per Person Total By Cost Center SSF VV SD Por Total LU/Per NSF/Per GSF/Per Linear Use Net SF Gross SF QC Bioassay** ,467 10,861 19,264 QC Stability ,713 6,293 Raw Materials ,300 7,957 12,953 Environmental QC ,512 9,975 19,660 In-Process Testing ,918 12,708 23,192 Reference Materials ,108 Marketed Products ,493 9,043 15,427 Microbiology** ,723 10,807 19,911 Validation Analytical Technology ,784 10,900 19,363 Biological Technology ,656 4,887 Quality Support 4 4 1,192 8,438 15,261 Totals , ,657 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 40

41 Ideal Lab Building 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 IFMA San Diego / March 2009 Intro to Life Sciences Facility Design 41

42 Thank You

43 IFMA San Diego Intro to Life Sciences Facility Design Presentation by Nancy Escano AIA, Managing Principal, DGA March 2009