Mixing Bio- and More Conventional Materials

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Jewel Hunter
5 years ago
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1 Mixing Bio- and More Conventional Materials UGIM Symposium 2016 Forum Session on Exotic Materials June 14, 2016

2 Mixing Bio and More Conventional Materials Bioelectronics Nano-biology Medical applications Diagnostic systems Novel applications o o o Targeted drug delivery Protein DNA nanowires Clathrin substrates

3 Bio Cleanroom Conflicting Needs Microelectronic Cleanroom for Semiconductor Device Fabrication o Cleanroom for low inanimate particulate count, ISO Class 6, 5, and better Microbiology and Cell Biology Work o The ability to manipulate & grow bacteria and virus, up to BSL-2 level o Can be ISO Class 6 or 7 but fully gowned, double gloves, personnel protection protocol Pharmaceutical Grade Work o Sterile environment (controlling bacterial count and preventing bacterial contamination) o Eliminate bacteria through protocols, gowning procedures, and wipe downs/sterilizations o Can be ISO Class 7, 6, or 5

4 Mixing Bio and More Conventional Materials Conflicts and Opportunities Microelectronics: o ISO Cleanrooms and Associated Controlled Environments Air Classification Design, Construction and Start-Up Pharmaceutical Applications o Code of Federal Regulations (CFR) 21 Part 211 Current Good Manufacturing Practices (cgmp) Biotechnology o National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories Example: Clathrin o o Can be used to form a functionalized lattice on many substrates Lattice formation and retention requires NaSCN (sodium thiocyanate) deadly to semiconductor circuitry

Opportunities Use of Laminar Flow Benches Use of BSL-2 Biosafety Cabinets to Manipulate and Culture Cells Glove Boxes for Precise Work in Surface Chemistry and Biology Substrate

5 Opportunities Use of Laminar Flow Benches Use of BSL-2 Biosafety Cabinets to Manipulate and Culture Cells Glove Boxes for Precise Work in Surface Chemistry and Biology Substrate Pass-throughs Transfer boxes (wafer box / sealed chamber) to Move Samples From Stationto-Station Under Contaminant-free or Sterile Environments RECIRCULATING BSC HZ LAMINAR FLOW CLEAN BENCH PASS THRU

6 Conflicts Construction Comparison Microelectronics Cleanroom Pharma Cleanroom cgmp Biology Cleanroom / Lab Non-monolithic systems Many joints Panelized Raised Floor / Solid Floor 2x2 Tiles Perforated panels Sheet Vinyl Demountable partitions Batten system Stick built Integral Grid Ceiling System Gasketed or Gel Seal Integral Lighting Drop In HEPA filters Monolithic Surfaces Minimize joints Facilitate sanitation/sterilization Seamless Flooring Welded Sheet Vinyl Troweled Epoxy Integral Coved Bases Partitions Gypsum Board/Epoxy Paint Coved Corners/Ceiling joints Stainless Steel Panels PVC panels Seamless Ceilings Gypsum Board/Epoxy Paint Surface Lighting Sealed terminal HEPA Semi-Monolithic Surfaces Minimize joints Facilitate decontamination Seamless Flooring Welded Sheet Vinyl Troweled Epoxy Integral Coved Bases Partitions Gypsum Board/Epoxy Paint PVC or Fiberglass panels Grid or Seamless Ceilings Washable lay-in panels (BSL1 & 2) Gypsum Board/Epoxy Paint Drop-in HEPA filters

Recommended Best Practices when Combining Separate, easily differentiated gowning protocols Separate entrance/gowning facility with separate security

7 Recommended Best Practices when Combining Separate, easily differentiated gowning protocols Separate entrance/gowning facility with separate security access, hand wash in/out for bio cleanroom Dedicated AHU s and airflow path Sealed bio-cleanroom floor with cove base (on grade or over microelectronics floor)

8 Purdue University Birck Nanotechnology Center LABS CHEM & BIO LABS BIO- CLEANROOM CLEANROOM

9 Purdue University Birck Nanotechnology Center Biological Cleanroom

10 Bio Cleanroom Cross Section

11 North Carolina Joint School of Nanoscience & Nanoengineering CHEM & BIO LABS CLEANROOM BIO-CLEANROOM

12 North Carolina Joint School of Nanoscience & Nanoengineering BIO-CLEANROOM BIO-GOWNROOM

14 Summary Concepts Conventional Fab Materials Semiconductor/Microelectronics Positive pressurization Protocols protect the sample / product (full gown, mouth rinse, etc.) Particulate cleanliness, wipe down exposed surfaces (IPA + water, etc.) Physical and Health Hazards (building code) Primarily protect the sample from the operator Negative pressurization Biological Materials Processing Protocols protect the user / environment (handwash in / out, double gloves, etc) Decontamination required, sterilize all surfaces (bleach + water, etc.) Physical, Health, and Biological hazards (building code + MBML) Primarily protect the operator from the sample

16 QUESTIONS?

17 Biotech Facilities Cell Culture Production Purification Suites Vaccine Production Protein Synthesis Medical Device Manufacturing

18 Pharmaceutical Facilities Solid Dosage Compounding Drug Delivery Systems Typically Aseptic

19 Microelectronics Facilities Crystal Pulling Wafer Manufacturing Chip Production Assembly/Test

Restricted Access Barrier Systems (RABS) & Isolators: The Perfect Combination of Robot System Safety and Aseptic Drug Manufacturing

MACHINE DESIGN AND MANUFACTURING Automated Systems of Tacoma 4110 South Washington St. Tacoma, WA 98409 (253) 475-0200 www.ast-inc.com Restricted Access Barrier Systems (RABS) & Isolators: The Perfect