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Guide for construction PMs on laboratory and life sciences facility projects including cleanrooms, vivariums, and GMP manufacturing.
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基于 SOC 职业分类
| name | life-sciences-lab-construction |
| description | Guide for construction PMs on laboratory and life sciences facility projects including cleanrooms, vivariums, and GMP manufacturing. |
Quick reference for construction project managers working on laboratory, research, pharmaceutical manufacturing, and life sciences facility projects.
| Facility Type | Key Regulations | Critical Systems | Reference File |
|---|---|---|---|
| Academic Research Labs | NIH Guidelines, OSHA 1910.1450 | Fume hoods, lab HVAC, gases | research-labs-academic.md |
| Corporate R&D Labs | OSHA, proprietary security | Flexible infrastructure | research-labs-corporate.md |
| Pharmaceutical Mfg | FDA 21 CFR 210/211, cGMP | Cleanrooms, HVAC, validation | pharmaceutical-manufacturing.md |
| Biotech Facilities | FDA, cGMP for biologics | Single-use, cold chain | biotech-facilities.md |
| Animal Facilities | USDA, AAALAC, PHS Policy | Vivarium HVAC, cage wash | vivarium-animal-facilities.md |
| Clinical/Diagnostic Labs | CLIA, CAP, state licensing | Specimen flow, LIS | clinical-labs.md |
| BSL | Risk Group | Key Features | Agents | Reference |
|---|---|---|---|---|
| BSL-1 | RG1 | Open bench, standard PPE | Non-pathogenic E. coli | biosafety-levels.md |
| BSL-2 | RG2 | BSC for aerosols, restricted access | Salmonella, Hepatitis B | biosafety-levels.md |
| BSL-3 | RG3 | Negative pressure, HEPA exhaust, decon | TB, SARS-CoV-2, Anthrax | bsl3-bsl4-containment.md |
| BSL-4 | RG4 | Suit lab or Class III BSC, full containment | Ebola, Marburg | bsl3-bsl4-containment.md |
| ISO Class | Particles ≥0.5μm/m³ | EU GMP Grade | Typical Application |
|---|---|---|---|
| ISO 5 | 3,520 | Grade A/B | Aseptic filling, critical zones |
| ISO 6 | 35,200 | - | Compounding, sensitive assembly |
| ISO 7 | 352,000 | Grade C | Background for Grade A/B |
| ISO 8 | 3,520,000 | Grade D | Gowning, less critical processing |
Detailed References:
| Regulation | Agency | Applicability | Reference |
|---|---|---|---|
| 21 CFR 210/211 | FDA | Drug manufacturing | fda-regulations.md |
| 21 CFR 600-680 | FDA | Biologics | fda-regulations.md |
| 21 CFR 820 | FDA | Medical devices | fda-regulations.md |
| 21 CFR 1301 | DEA | Controlled substances | dea-controlled-substances.md |
| NIH Guidelines | NIH | rDNA research | nih-rdna-guidelines.md |
| 9 CFR Parts 1-4 | USDA | Animal welfare | usda-aaalac-requirements.md |
| 29 CFR 1910.1450 | OSHA | Lab safety | osha-lab-safety.md |
| ISO 14644 | ISO | Cleanroom standards | iso-classification.md |
| System | Key Parameters | Critical Issues | Reference |
|---|---|---|---|
| Lab HVAC | 6-12 ACH, 100% OA typical | Pressure relationships, exhaust diversity | lab-hvac-systems.md |
| Lab Gases | N2, CO2, compressed air, specialty | Storage, distribution, alarming | lab-gases.md |
| Pure Water | RODI, WFI, USP grades | Loop design, sanitization | pure-water-systems.md |
| Emergency Power | Critical equipment, freezers | UPS for sensitive loads | emergency-power-ups.md |
| Vibration/EMI | VC curves, shielding | NMR, EM, mass spec requirements | vibration-emi-control.md |
| Equipment | Key Requirements | Installation Issues | Reference |
|---|---|---|---|
| Fume Hoods | 80-100 fpm face velocity | Exhaust, make-up air, ASHRAE 110 | lab-casework-fume-hoods.md |
| Biosafety Cabinets | NSF 49 certified, Class II types | Exhaust connection, room balance | biosafety-cabinets.md |
| Autoclaves | Steam, water, drain, exhaust | Floor loading, pass-through | autoclaves-sterilization.md |
| Cold Storage | -80°C ULT, LN2 cryogenic | O2 monitoring, backup power | cold-storage-cryogenic.md |
| Specialized Equipment | NMR, EM, mass spec | Vibration, EMI, utilities | specialized-equipment.md |
| Topic | Key Requirements | Reference |
|---|---|---|
| Facility Design | AAALAC, USDA, species requirements | vivarium-animal-facilities.md |
| Housing | IVC racks, environmental control | vivarium-housing.md |
| Cage Wash | Tunnel/cabinet washers, clean/dirty separation | cage-wash-sterilization.md |
| Procedures | Surgery, imaging, necropsy | animal-procedure-imaging.md |
| HVAC | 10-15 ACH, odor control | vivarium-hvac-odor.md |
| Element | Key Considerations | Reference |
|---|---|---|
| Pressure Cascades | Positive/negative, differentials | pressure-cascades-airlocks.md |
| Airlocks | PAL, MAL, interlocks | pressure-cascades-airlocks.md |
| Gowning | Sequences, room sizing | gowning-sequences.md |
| Environmental Monitoring | Viable, non-viable, continuous | environmental-monitoring.md |
| Phase | Purpose | Reference |
|---|---|---|
| IQ | Installation Qualification - verify installation | iq-oq-pq-validation.md |
| OQ | Operational Qualification - verify operation | iq-oq-pq-validation.md |
| PQ | Performance Qualification - verify performance | iq-oq-pq-validation.md |
| Certification | Cleanroom testing per ISO 14644 | cleanroom-certification.md |
| Stakeholder | Role | Key Concerns | Reference |
|---|---|---|---|
| Principal Investigators | Research leads | Lab functionality, schedule | life-sciences-stakeholders.md |
| EHS | Safety oversight | Compliance, hazard control | life-sciences-stakeholders.md |
| IBC | Biosafety review | BSL requirements, containment | life-sciences-stakeholders.md |
| IACUC | Animal care oversight | Vivarium compliance | life-sciences-stakeholders.md |
| Quality Assurance | GMP compliance | Validation, documentation | life-sciences-stakeholders.md |
| Division | Life Sciences Scope | Reference |
|---|---|---|
| 08 | Lab doors, hermetic, chemical resistant | specifications-csi.md |
| 09 | Epoxy floors, cleanroom finishes | specifications-csi.md |
| 10 | Safety stations, lab accessories | specifications-csi.md |
| 11 | Fume hoods, BSCs, autoclaves | specifications-csi.md |
| 12 | Lab casework, furniture | specifications-csi.md |
| 13 | Cleanrooms, shielded rooms | specifications-csi.md |
| 22 | Lab plumbing, pure water | specifications-csi.md |
| 23 | Lab HVAC, fume hood exhaust | specifications-csi.md |
| 26 | Lab electrical, clean power | specifications-csi.md |
| Issue | Impact | Prevention |
|---|---|---|
| Pressure balancing failures | Contamination, containment breach | Early TAB involvement, door interlocks |
| Fume hood diversity miscalculation | Insufficient exhaust capacity | Verify diversity with lab users |
| Vibration transmission | Sensitive equipment malfunction | Vibration study, structural isolation |
| Pure water loop dead legs | Microbial contamination | Review loop design, slope to drains |
| Cleanroom finish defects | Particle generation, cleaning issues | Mock-up approval, installer training |
| Validation documentation gaps | Regulatory delays, re-work | Validation master plan early |
| Equipment utility mismatches | Delayed equipment startup | Verify OFE requirements early |
| Change control violations | GMP non-compliance | Establish change control process |
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