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YOKO-CRS
Pharmaceutical Clean Room System
YOKO-CRS is a pharmaceutical cleanroom project scope rather than a standalone machine. It can coordinate the architectural envelope, HVAC and filtration, pressure zoning, process and drainage interfaces, electrical distribution, controls, and commissioning records around a defined manufacturing process. Classification, environmental limits, materials, utilities, and qualification deliverables must be set by the user's applicable regulations and quality system.
- Reference capacity / range
- Confirmed for the selected product and format
- Dimensions
- Confirmed for the selected configuration
- Power
- Confirmed for the selected configuration
Typical applicationSolid-dosage manufacturing and packaging areas · Liquid preparation, filling, and supporting clean areas
Material or formatInsulated wall and ceiling panels with compatible joints and finishes · Cleanroom doors, windows, floors, coving, and sealed penetrations
Equipment purpose
What this machine is designed to do
The system is intended to create controlled production spaces that support the required product-protection, personnel-protection, contamination-control, and operational flows. The supplied boundary may range from selected rooms and HVAC packages to a coordinated cleanroom fit-out, but every project begins with a user requirement specification and an agreed responsibility matrix.
Operating sequence
Working principle
Conditioned air is filtered, supplied, returned, or exhausted according to the room classification and process risk. Air quantities, pressure differentials, temperature, humidity, recovery behaviour, and containment are balanced with equipment heat loads, occupancy, door operation, exhaust demand, and material or personnel movement. Monitoring and alarms show whether defined environmental conditions are maintained; commissioning and qualification then verify the installed system against the approved design and test methods.
Review points
- The project can coordinate architectural, HVAC, plumbing, electrical, control, and equipment-interface work under one defined scope.
- Room data sheets and pressure-zoning drawings connect the process risk assessment to airflow and construction decisions.
- Equipment heat, moisture, dust, solvent, exhaust, and maintenance access must be included before HVAC sizing is frozen.
- Legacy class references in source tables are planning references only and must be mapped to the current standard required by the destination market.
- Commissioning and qualification records are defined in advance; terminology such as IQ, OQ, airflow visualization, recovery, HEPA integrity, or room classification is used only when included in the agreed protocol.
- A responsibility matrix should identify design inputs, approvals, builders' work, utilities, testing, training, spares, and post-handover support.
Process fit
Applications and compatible materials
Use these references to frame the first technical discussion. Suitability is confirmed with actual material, format, and process data.
Typical applications
- Solid-dosage manufacturing and packaging areas
- Liquid preparation, filling, and supporting clean areas
- Nutraceutical, food, laboratory, or electronics rooms after requirement review
- Material airlocks, personnel airlocks, corridors, and controlled support spaces
Material or format references
- Insulated wall and ceiling panels with compatible joints and finishes
- Cleanroom doors, windows, floors, coving, and sealed penetrations
- Air-handling, terminal filtration, ductwork, dampers, and exhaust components
- Process utility, drainage, electrical, monitoring, and control components within scope
Reference parameters
Technical specifications
Values are model references for initial selection. The quotation and approved technical agreement define the final supplied configuration.
Technical specifications
| Air Cleanness Class | The maximum allowable number of suspended particles (pcs/m²) / The maximum allowable number of suspended microorganisms |
|---|---|
| ≥0.5um | ≥5um / Plank tonic bacteria (cfu/m²) / Settling microbe (cfu/DISH) |
| 100 | 3500 / 0 / 5 / 1 |
| 10000 | 350000 / 2000 / 100 / 3 |
| 100000 | 3500000 / 20000 / 500 / 10 |
| Cleanliness Level | DUST Count/m² / Microbial Number/m² / Ventilation Rate/h |
| ≥0.5um | ≥5um |
| 10 000 Class | ≤350 000 / ≤2 000 / ≤100 / ≥20 TIME |
| 100 000 Class | ≤3500 000 / ≤20 000 / ≤500 / ≥15 TIME |
Before quotation
Configuration inputs
A useful quotation starts with the product, container or format, target output, available utilities, and destination requirements.
- Concept design, room data sheets, zoning, layouts, and detailed engineering
- Wall, ceiling, door, window, floor, coving, and penetration-sealing package
- HVAC, filtration, return or exhaust, pressure control, and environmental monitoring
- Process utilities, plumbing, drainage, electrical distribution, lighting, and controls within scope
- Airlocks, pass boxes, transfer interfaces, equipment penetrations, and maintenance access
- Commissioning, testing, qualification support, training, handover documents, and service scope
Need a model-specific document?
Ask for the current datasheet, layout information, and available documentation package.
Request documentsSupporting files
Videos and technical documents
Availability varies by model and configuration. Request the current demonstration, datasheet, layout, or documentation package when needed.
Datasheet or manual
Download YOKO technical datasheetModel-specific operating manuals and layout files are supplied after configuration review.
Selection questions
Frequently asked questions
What information is required before a YOKO-CRS cleanroom design starts?
Provide the process flow, products and hazards, destination regulations, target classifications, room list and sizes, equipment layouts and loads, occupancy, material and personnel routes, waste route, temperature and humidity limits, pressure strategy, exhausts, utilities, cleaning agents, monitoring expectations, available building conditions, and required qualification documents. Missing inputs should be recorded as assumptions for approval rather than silently fixed in the design.
Does a cleanroom classification alone define the HVAC system?
No. Classification is only one input. Air volume and system architecture also depend on heat and moisture loads, recovery requirement, pressure cascade, door use, leakage, filtration, exhaust, process emissions, occupancy, redundancy, cleaning, energy targets, and local outdoor conditions. The final design must be calculated from the room and process data.
How should the legacy Class 10,000 and Class 100,000 data be used?
Treat those source-table values as historical references, not as the project acceptance standard. The user should identify the current classification framework and regulatory expectations that apply to the facility. The design team can then map terminology, particle limits, room states, test locations, microbiological programme, and acceptance methods in controlled project documents.
What qualification work can be included?
The scope may include document review, installation checks, airflow volume and balance, pressure differentials, HEPA-filter integrity, particle classification, temperature and humidity mapping, recovery testing, alarms, airflow visualization, and other agreed tests. Exact protocols, room state, instruments, sampling, acceptance criteria, deviations, and responsibilities must be approved before execution.
How can scope gaps between cleanroom and production equipment be avoided?
Use a room-by-room equipment schedule and interface matrix. Record power, compressed air, vacuum, water, steam, drains, exhaust, heat release, floor loading, openings, transfer heights, controls, network points, installation routes, access for maintenance, and sealing responsibilities. Review the matrix with the building, cleanroom, utility, and equipment teams before drawings are released.
Continue the line review
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- Reference range
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Model-level review
Request a configured quotation for YOKO-CRS
Share the material, product format, target sustained output, available utilities, destination standard, and expected documentation scope.
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