Service 26 / 27 · QC & Microbiology Laboratory Engineering
A Laboratory Is Only as Reliable as Its Layout.
Laboratories are often planned last and squeezed into the space that remains, which is where sample routes cross, microbiology shares air with production and incubators end up in corridors. ALVEDA plans QC and microbiology laboratories from their workflows: how samples arrive, where analytical and microbiological work is separated, what environment a sterility test needs, and how media, chemicals, glassware and waste move. Equipment, environmental conditions and utility requirements are defined room by room so that architecture, HVAC and MEP can design to a clear brief.
Engineering phases
Where this service fits
04 / 09 phases in scope
- 01Feasibilitynot in scope
- 02ConceptIn scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05Procurementnot in scope
- 06Constructionnot in scope
- 07CommissioningIn scope
- 08Validationnot in scope
- 09Operationnot in scope
Scope
What the service covers
- 01Laboratory zoning and room program
- 02Analytical and microbiology workflow separation
- 03Sterility-testing environment planning
- 04Sample, personnel and laboratory waste flow
- 05Media, chemical and consumable storage
- 06Equipment, environmental and utility requirements
Method
From inputs to deliverables
INInputs
06 items- I01Testing scope: raw material, in-process, finished product and environmental samples
- I02Expected sample volumes and turnaround
- I03Analytical and microbiological methods in use or planned
- I04Hazardous samples or reagents, as identified by the client
- I05Existing equipment to be relocated
- I06Quality requirements defined by the client
WORKActivities
06 items- W01Workflow mapping per test type
- W02Room program and adjacency planning
- W03Definition of classified areas for sterility testing
- W04Equipment planning and bench layout
- W05Environmental and utility requirements per room
- W06Coordination with HVAC, MEP and architecture
OUTDeliverables
05 items- D-26.01Laboratory room program and zoning layout
- D-26.02Sample, personnel and waste flow diagrams
- D-26.03Laboratory room data sheets
- D-26.04Equipment list and layout
- D-26.05Utility and environmental requirements schedule
Technical detail
Laboratory planning topics
Contents · 06
01 / 06
Laboratory zoning & workflow
Analytical chemistry and microbiology have different risks and should not share the same route or air without a reason.
- Analytical laboratory zoning
- Microbiology laboratory zoning
- Separation from production areas
- Office and documentation areas outside the laboratory workflow
02 / 06
Sterility-testing environment
Sterility testing needs a controlled environment of its own, with entry, gowning and material transfer planned like a small cleanroom suite.
- Classified room or isolator concept
- Personnel entry and gowning
- Material transfer and pass boxes
- Pressure and airflow interfaces
03 / 06
Sample & personnel flow
- Sample receipt, logging and distribution
- Retained-sample storage
- Personnel routes between laboratory areas
- Hazardous-sample handling points
04 / 06
Storage, washing & incubation
- Media preparation and storage
- Chemical and reagent storage with segregation
- Glassware washing and drying
- Incubation areas and controlled-temperature storage
- Autoclave and decontamination interfaces
05 / 06
Laboratory waste flow
- Biological waste decontamination before removal
- Chemical waste collection and holding
- Hazardous-sample waste segregation
- Waste exit route separate from clean supplies
06 / 06
Environmental conditions & utilities
- Temperature, humidity and pressure requirements per room
- Fume hoods, BSCs and local exhaust
- Purified water, gases, vacuum and compressed air
- Power quality and backup for critical equipment
- Data and monitoring points
Deliverables
Typical documents and outputs
- D-26.01Laboratory room program and zoning layout
- D-26.02Sample, personnel and waste flow diagrams
- D-26.03Laboratory room data sheets
- D-26.04Equipment list and layout
- D-26.05Utility and environmental requirements schedule
Services
Related services
- 22
Environmental Monitoring Strategy
Viable, surface, pressure, temperature and humidity monitoring planned with instruments and data logging.
- 06
Process Utilities
Steam, air, gases, water and drainage systems sized and specified for regulated production.
- 24
Facility Zoning & Flow Studies
Classification zones and personnel, material and waste routes resolved before the layout is fixed.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700