How to start a clean room: guide from idea to start-up

Key points on how to start a clean room:

• An air rating should not be chosen or the space designed without first having mapped workflows, personnel, raw materials and waste.
• A clean room project requires integrating fluid engineering, sanitary architecture, HVAC air conditioning, absolute filtration and quality assurance.
• Finishing the physical construction does not imply that the room is operational; It is mandatory to execute the physical and instrumental validation tests before starting production.
• The requirements vary by sector; While ISO 14644 classifies cleaning by particles, GMP standards in the pharmaceutical industry o Cosmetics add strict microbiological and documentary controls.
• Having a single technical partner like Labsom simplifies execution from consulting services initials until start-up and subsequent Maintenance of clean rooms.

Before drawing the foregrounds or selecting the enclosure materials, the technical direction must respond to three fundamental pillars:

What activity is going to be done inside the room?

It is necessary to accurately identify the processes that will be developed inside (eg formulation of Medical cannabis, packaged in White rooms for cosmetics). The raw materials, the volatile or biological reagents, the equipment that will generate thermal loads and the number of operators who will work per shift should be listed.

What cleanliness, safety and regulations should you meet?

Determine the regulatory requirements applicable to the sector. Not all rooms require the same purity of the air; Classification must be justified by risk analysis. It must be defined if the product requires particle protection, if the personnel needs containment by Biosafety levels or if the facility must pass sanitary inspections (AEMPS, FDA).

What space, budget and resources do you have available?

Evaluate the conditions of the property or warehouse available: free height up to the floor, mechanical resistance of the floor, availability of electrical connections, accesses for the supply of future growth equipment and forecasts. Determine the global budget considering the direct installation costs and the continuous operating costs of energy and maintenance.

the life cycle of the implantation of a clean room It is structured in six successive phases:

Phase 1. Definition of user requirements and requirements (URS)

User requirements are collected (user requirement specifications). This document details the required technical variables: temperature, relative humidity, particle limits, differential pressure jumps and expected workflows.

Phase 2. Conceptual design and engineering

The stages of conceptual, basic and detailed engineering are developed. through the White Room Design, Layout plant architecture, zoning plans, distribution of corridors, HVAC air conditioning network, filtration and fluid and electricity connections.

Phase 3. Budget, planning and execution of the work

The temporary planning is approved (Gantt) and the works on the ground floor are carried out. Includes installation of insulating sanitary paneling, continuous resin floors, false technical recordable ceilings and placement of Types of doors for clean rooms.

Phase 4. Installation of equipment and control systems

The process machinery and local containment systems are positioned, such as laminar flow booth or the Biological safety booths. The network of fixed sensors of the platform is connected White room monitoring in real time.

Phase 5. Receive tests (FAT/SAT), qualification and validation

Before starting the qualification in the plant, the FAT (Factory Acceptance Testing) tests are carried out at the manufacturers’ facilities to check the previous operation of critical equipment (such as UTAs or Pasajes SAS). Following on-site assembly, SAT (Site Acceptance Testing) tests are performed to verify that the systems have been successfully received and interconnected. Subsequently, the instrumental tests of the qualification of the installation (IQ), operation (OQ) and performance (PQ) are executed to issue the final validation dossier.

PHASE 6. START-UP AND TRAINING OF STAFF

Standardized operating procedures (SOP) for entry and exit of personnel, sterile clothing, biocidal cleaning protocols, material management in the Pass box systems and action against technical deviations.

For an enclosure to function in a coordinated manner, the project engineering must include five fundamental systems:

• Air conditioning, ventilation and filtration of the air (HVAC): Air treatment units (UTAS) sized to ensure hourly renovations needed and equipped with HEPA H14 filters for absolute particle retention.
• Sanitary Enclosures and Finishes: Phenolic or lacquered steel paneling without porosity, epoxy resin floors with half-round profiles in the corners and flush windows.
• Electricity, lighting and auxiliary services: Waterproof lighting (whose lux level is determined according to the requirement of the visual task and the standard applicable to the sector), protected power outlets, purified water lines (PW), technical vacuum, compressed air free of oil and high purity gases.
• Control of pressure, temperature, humidity and particles: Automation panels and regulation gates to maintain the cascade of positive or negative pressures according to the level of containment required.
• Work equipment, furniture and security: integration of white room furniture In stainless steel AISI 304/316L, safety showers and Door interlock for clean rooms.

The applicable regulatory framework is determined based on the intended use of the facilities:

ISO 14644 standard and clean room classification

It is the international reference engineering standard. Regulates the maximum particle concentration per cubic meter of air (Part 1), verification tests in situ (Part 3) and the Design and Construction Guidelines (Part 4). To understand the limits of each category, you can consult our guide on the Classroom classification according to ISO 14644.

GMP Requirements for Pharmaceutical Projects

If the room is intended for the manufacture of sterile medicines in the White rooms for the pharmaceutical industry, must comply with Annex 1 of the EU GMP, classifying the environments in grades A, B, C and D based on microbiology and particles at rest and in operation.

Specific regulations by sector

Additional regulations such as the ISO 22716 of Good Manufacturing Practices in the Cosmetic Industry, the UNE 171340 Standard for Controlled Environment in the Operating Rooms or the AEMPS Guidelines for the Management of Medical Devices.

Technical documentation and records

To demonstrate legal compliance with an audit, the plant must retain sensor calibration reports, HEPA filter integrity certificates, and the continued recording of environmental variables.

Determining the technical aptitude of a clean room requires differentiating the completion of the civil works from the operational qualification of the stay:

1. Verification of facilities and equipment: Check that the panels, doors, lights and air conditioners are installed according to the approved engineering plans.
2. Verification of environmental parameters: Measure the air injection flow rate, air velocity, hourly renovations, temperature, humidity, and the differential pressure jump between adjacent rooms.
3. Qualification and validation of results: Perform particle count according to ISO 14644-1 in resting state (at-rest) and in operation (operational), together with the integrity tests of HEPA filters and contamination recovery tests for the emission of IQ, OQ and PQ qualifications. 
4. User training and approval of SOPS: Confirm that the staff knows the protocols for hygiene, aseptic technique, clothing and response to pressure loss alarms.

• Define the space without knowing the real needs of the process: Build a generic room without considering the final machinery or thermal loads of the process.
• Choose an ISO classification without technical justification: Selecting an excessively strict degree of cleanliness unnecessarily increases the installation budget and the electric bill for the air conditioners.
• Leave for the end the flows of personnel and materials: Do not project independent passage locks, causing crosses between dirty zones and classified areas.
• Do not anticipate maintenance and operating costs: Ignore the cost of substitution of pre-filters, periodic requalifications and energy consumption of the HVAC system.
• Postpone qualification tests until delivery: Do not carry out intermediate checks during the assembly of ducts or panels, making it difficult to correct the correction of hidden air leaks.
• Do not document procedures or train staff: Allow access to operators without adequate training in standards of behavior within clean areas.

Launching a clean room requires the coordination of specialists in multiple technical areas. Entrusting the project to different non-specialized contractors usually leads to time deviations and sealing problems during final validation.

On LABSOM We offer a comprehensive turnkey service that covers all phases of your installation life cycle:

• consulting services and cleanroom engineering: Initial regulatory advice, definition of user requirements (URS), conceptual design and calculation of the HVAC system.
• Construction and assembly on the floor: execution of sanitary civil works and supply of adaptable alternatives such as our Modular white rooms.
• Equipment and enclosures: installation of panels, waterproof doors, white room furniture and containment booths.
• Cleanroom validation: Instrumental tests, issuance of official qualification reports (IQ/OQ/PQ) and delivery of the dossier of the installation.
• Cleanroom maintenance: Periodic preventive programs, substitution of absolute filters and annual requalifications.

Do you have a clean room project for your company in mind? Contact the Labsom technical team And we will accompany you from the initial idea to the definitive start-up.