Cleanroom Design

American Cleanroom Systems® are experts in cleanroom design and have extensive experience designing, manufacturing, and installing modular cleanrooms for leading pharmaceutical, medical device and industrial companies.

Cleanroom Design Features:

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Low velocity vertical laminar air flows to maximize cleanroom effectiveness and efficiency.

MEP design including heat load, exhaust cfm, make up air, hardware specification and system design.

Electrical design including lighting, electrical outlets, panels and wiring diagrams.

Uniform temperature and humidity control and distribution for maintaining cleanroom environment specifications.

Floor to ceiling clear viewing panels provide improved worker and manufacturing visibility.

Custom environmental systems for tight temperature and humidity requirements.

Cleanroom Design Capabilities:

American Cleanroom Systems® has extensive experience designing and engineering custom cleanrooms to unique and strict requirements for pharmaceutical, medical device and industrial cleanroom clients. Our design team creates and provides complete design specifications for each project.

Custom Design Based On:

• GMP requirements
• Product flows
• Personnel flows
• Cleaning protocols

• Process heat load
• Exhaust requirements
• T/RH requirements

Design Capabilities:

• Architectural design
• Structural
• Plenum / HEPA FFU / Returns
• Electrical
• HVAC

• Flooring
• Modular, softwall, standard, hybrid
• Team has 150 years cleanroom experience
• License General Contractor

Electronics Modular Cleanroom

• Class 110 / ISO-5
• 8000 SF
• Comfort Cooling
• Class "A" non-combustible modular walls

Manufacturing Modular Cleanroom

• Class 100k / ISO-8
• 1000 SF
• Floor to Ceiling Glass Walls
• Conveyor Openings
• Motorized Roll Up Doors

Modular Cleanroom

• Class 100 / ISO-5
• 2000 SF
• Equipment Mezzanine
• Motorized Rollup Door for Equipment Loading
• Static Dissipative Modular Walls

Chiller for Research & Development Modular Cleanroom

• Class 100 / ISO-5
• 5000 SF
• +-1 degree temperature
• +-5% relative humidity controls

Cleanroom Standards:

• Class 100-100k, ISO5-8, ISPE, USP797/800, Title 24, MIL-STD

Cleanroom Engineering:

• Professional engineers.
• AUTOCAD Designs.
• Drawings and engineering calculations for permits.

Construction Options:

Modular Cleanroom
SQFT: 2000 SF
Cleanroom Class: Class 100 / ISO-5
Specific Requirements:

• Equipment Mezzanine
• Motorized Rollup Door for Equipment Loading
• Static Dissipative Modular Walls

Additional Construction Options:

• Standard, softwall and hybrid.
• Custom equipment enclosures.
• Glass panel walls.
• Wipe down, wash down, non-combustible, fire-rated, and insulated wall construction

Filter Options:

• Negative pressure plenum with HEPA FFU, open plenum with mixing boxes, ducted with static HEPA.
• Positive and negative pressure rooms.
• Exhaust systems – standard and BIBO.

We have extensive experience working with end-users, general contractors, architects and engineering firms.

Cleanroom Air Flow – Recirculating Modular Cleanroom

FAQs About Cleanroom Design

Q: Are There Any Standard Cleanroom Design Requirements?

A:

• HEPA filtration air flow per ISO 14644-1 / US FED STD 209E cleanroom standards
• Low velocity vertical laminar HEPA filtered air flows to maximize cleanroom effectiveness and efficiency (see cleanroom air flow diagram)
• Low all air returns to create vertical ceiling to floor HEPA filtered air flow – sweeping particulates down to floor level then out of cleanroom
• Positive air pressure vs. outside cleanroom to prevent contamination from entering cleanroom.
• Magnehelic gauges to monitor and measure room pressure
• Cleanroom classified gowning room so workers can put on cleanroom smock, booties, and hoods to reduce particulates in cleanroom
• Cleanroom classified material transfer room or interlocked pass thru to avoid introducing particulates into the cleanroom when bringing material in or out.
• Cleanroom heat welded vinyl or epoxy flooring to ensure flooring is not source of particulates
• Cleanroom vinyl coated ceiling tiles to ensure ceiling is not source of particulates
• Cleanroom sealed ceiling lighting to ensure ceiling is not source of particulates

Q: What is a Pharmaceutical Cleanroom?

A: Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharmaceutical cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

Q: What is The Purpose of a Cleanroom?

A: Cleanrooms are used in any industry that wants to control contamination in their facility. It is common to see pharmaceutical cleanrooms, medical device cleanrooms, semiconductor cleanrooms, electronic cleanrooms, aerospace cleanrooms, food cleanrooms, USP797 compounding pharmacy cleanrooms and biotech cleanrooms. Cleanrooms are also used by the government such as national labs, defense industries, and R&D labs at universities.

Q: What Are Cleanroom Requirements?

A: Most common cleanroom requirements include cleanroom classification, size, number of rooms, cleanroom flooring, cleanroom ceiling height, cleanroom chemical resistance, and cleanroom temperature and humidity.

Request A Cleanroom Project Quote

Are you ready to build your cleanroom or need a quote for budgetary and planning? Contact American Cleanroom Systems® at (949) 589-5656 or Complete our Online RFQ Form.