Resources

Plan your room before you ask for prices

Guides and tools for buyers, engineers and contractors.

Modular operating theatres: scope, air and pressure standards

What a modular operating theatre includes, with air change, pressure and filter values from UK, US and Indian standards. For engineers and buyers.

Cleanroom HVAC design: AHU, recirculation and FFU options

How to choose between a central AHU, recirculation and ceiling FFUs for a cleanroom, with air speed and filter values and who designs what.

Cleanroom panel selection: core materials compared

Compare rock wool, hollow MgO, silica rock, PU, honeycomb and EPS cleanroom panel cores on fire class, weight and use, with the tests to ask for.

Cleanroom pressure differentials: cascades, values, monitoring

How pressure cascades work, published values from EU GMP, FDA, China GMP, UK and Indian hospital guidance, and what to monitor and alarm.

Cleanroom doors: hinged, sliding and hermetic selection

Compare hinged, sliding and hermetic cleanroom doors, with leakage figures, EN 12207 classes, interlock rules and finish checks for engineers.

Battery dry room design: dew point, dehumidification, envelope

Dew point targets, moisture load, dehumidification and envelope tightness for lithium battery dry rooms, with calculated moisture values and sources.

Writing a cleanroom URS: contents and testable wording

How to write a cleanroom user requirement specification, with a contents table, testable wording and the checks that tie design and handover to it.

How to audit a cleanroom panel factory, on site or by video

A checklist for auditing a cleanroom panel factory on site or by video: certificates, test reports, line checks and how to run a remote audit.

ISO 5 and ISO 6 cleanroom requirements

ISO 14644-1 particle limits for ISO 5 and ISO 6 rooms, published airflow reference values, and what to write in the room list. For engineers and buyers.

Cleanroom flooring options: epoxy, vinyl, raised and static control

Compare epoxy, sheet vinyl, raised access floor and static-control floors for cleanrooms, with GMP, USP and ESD values. For engineers and buyers.

FFU ceiling layout: coverage, class and grids

How to size an FFU ceiling from airflow, with ceiling coverage arithmetic, published air velocity and air change values, and test steps.

HEPA and ULPA filters: EN 1822, ISO 29463 and integrity testing

EN 1822 filter classes E10 to U17, the matching ISO 29463 classes, and how installed filters are leak tested. For engineers and buyers.

Air shower and pass box selection

How to choose an air shower, static or dynamic pass box, or airlock, with interlock and pressure rules from EU GMP, FDA and USP. For buyers.

Gowning room design: airlocks, zones and sequence

How to lay out a gowning room as a chain of airlocks, with EU GMP Annex 1, FDA and USP <797> rules on zones, doors, pressure and sinks.

USP <797> compounding cleanroom for hospital pharmacy

USP <797> room classes, air changes, pressure, surfaces and certification for hospital pharmacy sterile compounding rooms.

Cleanroom monitoring systems: particles, pressure, temperature and humidity

What a cleanroom monitoring system measures: particles, pressure, temperature and humidity, with limits and sampling rules from EU GMP, FDA and USP.

How to choose a cleanroom contractor: questions and evidence

Questions to ask a cleanroom contractor, the evidence to demand, and fair checks when you buy from a Chinese supplier. For project buyers.

Building a cleanroom inside an existing building

How to fit a cleanroom into an existing building: height, structure, air plant, services, fire, and building beside live operations.

Upgrading an existing cleanroom for EU GMP Annex 1: gap list

Facility and air gap list for existing sterile cleanrooms under EU GMP Annex 1 (2022): airlocks, pressure, surfaces, qualification and monitoring.

Hospital isolation room design: pressure, air and layout

Negative, positive and lobby isolation rooms: air changes, pressure, layout and checks from CDC guidance and UK HTM 03-01.

Cleanroom airlock design: bubble, cascade and sink

How bubble, cascade and sink airlocks work, with pressure steps, interlock rules and door leakage figures from Annex 1, FDA and UK HTM 03-01.

Hardwall vs softwall cleanroom: how to choose

How hardwall panel rooms and softwall curtain rooms differ on sealing, pressure, cleaning, fire and change, and what evidence to ask for.

Cleanroom air changes per hour: published values and their limits

Published air change values by cleanroom class and use, with sources, the formula, a worked example and why they are only starting points.

Cleanroom temperature and humidity requirements

Published temperature and humidity ranges for pharmacy, hospital and electronics rooms, why ISO 14644-1 sets none, and a dew point table.

Cell and gene therapy cleanroom design: grades, segregation and flows

Which grades cell and gene therapy rooms need under EU Part IV for ATMPs: open and closed processing, segregation, airlocks and flows.

BSL-3 laboratory design: facility and air features

Facility and air features of a BSL-3 laboratory from the CDC and NIH BMBL 6th edition: entry, directional airflow, sealing, HEPA and testing.

Cleanroom cost per m²: published ranges by ISO class

Published cleanroom cost ranges by ISO class from US and European sources, shown per m² and per sq ft. Industry figures, not quotations.

Cleanroom failed particle count: causes and fixes

Why a cleanroom fails a particle count, and how to check the counter, filters, airflow and people. Limits from EU GMP Annex 1 and FDA guidance.

Cleanroom pressure alarm: how to find the cause

How to find the cause of a low cleanroom pressure alarm: doors, supply fan, filters, leakage paths and sensors. Guidance from Annex 1, FDA and HTM 03-01.

HEPA filter integrity and leak testing

How an installed HEPA filter leak test works: aerosol challenge, scan, the 0.01% limit, test intervals and repair. From FDA guidance, Annex 1 and HTM 03-01.

Pass box qualification: DQ, IQ, OQ and PQ

What each qualification stage covers for a cleanroom pass box, which tests an active pass box may need, and which documents to ask for. Annex 15 and Annex 1.

Contamination control strategy: what the building and air must provide

What a contamination control strategy needs from the building and air: grades, airlocks, pressure, airflow, surfaces and tests. Mapped to EU GMP Annex 1.

Aseptic filling suite layout: grade A and B rooms and flows

How to lay out an aseptic filling suite: grade A filling zone, grade B background, airlocks and one-way flows for people, materials and waste. Annex 1 and FDA.

Cleanroom wall and ceiling finishes: coving, sealants, joints and stainless steel

What cleanroom walls and ceilings need: smooth unbroken surfaces, rounded corners, sealed joints and penetrations, and where stainless steel fits.

What a cleanroom costs to run: energy, filters and testing

What drives cleanroom running cost: fan energy, air volume, filter resistance and replacement, and testing intervals. Drivers only, with no price figures.

What is a cleanroom? How it works and what to do next

A plain introduction to cleanrooms: how filtered air, pressure, surfaces and entry routes control particles, how ISO classes work, and what to decide next.

Cleanroom panel installation: sequence, tolerances, sealing and faults

Cleanroom wall and ceiling panel installation: typical sequence, EN 14509 factory tolerances, sealing rules, leak testing and common faults.

Cleanroom ceiling systems: walkable, non-walkable, grids and loads

Walkable and non-walkable cleanroom ceilings, including rock wool and paper honeycomb ceiling panels: sealing, grids, loads and fire tests.

Cleanroom windows and view panels: when needed, fit and seal

How to specify cleanroom windows and view panels: when GMP asks for them, flush fit, sealing, fire test routes and a window schedule checklist.

Static vs dynamic pass box: how to choose

Static and dynamic pass boxes compared: air flushing, interlocks, sampling and what EU GMP, USP <797> and Chinese standards say.

Fan filter unit selection: fan type, noise, control and sizing

How to select fan filter units: motor type, airflow and uniformity, noise, control and sizing, with LBNL, FDA and EU GMP references.

Cleanroom lighting: lux, sealed fixtures and teardrop luminaires

Cleanroom lighting rules: sealed flush fixtures, airflow around luminaires, where the lux level comes from and what to test at handover.

Laminar flow hood vs clean bench vs biosafety cabinet

Laminar flow hood, clean bench and biosafety cabinet compared: air direction, who is protected, inflow speeds and annual certification.

Softwall and portable cleanroom booths: fit and realistic class

When a softwall, portable or shipping container cleanroom suits, and which ISO class you can claim: particle limits, air changes, leakage and fire tests.

Operating room laminar flow ceilings: size, air speed and filters

Size, air speed, filter grade and noise values for an operating room laminar flow ceiling, taken from UK HTM 03-01 Part A, with a worked example.

Pharmaceutical cleanroom zoning: grades, airlocks and pressure steps

How to zone a sterile pharmaceutical plant: grades A to D, particle and microbial limits, airlocks and pressure steps, from EU GMP Annex 1 and FDA.

Food factory hygienic zoning: raw, ready-to-eat and support areas

How to split a food plant into raw, ready-to-eat and support zones, with FDA four-zone monitoring definitions, air pressure advice and filter values.

Semiconductor cleanrooms: vibration criteria and airborne molecular contamination

Vibration criteria VC-A to VC-E, airborne molecular contamination categories and ISO 14644-8 scope for semiconductor cleanroom design.

Medical device cleanrooms: writing ISO 13485 design inputs

How to write cleanroom requirements as design inputs under ISO 13485 clause 7.3.3, with FDA's summary, ISO class limits and a worked example.

Cosmetics factory rooms: what ISO 22716 and regulators say about premises

What FDA, Health Canada and EU rules say about cosmetics factory premises under ISO 22716, a room checklist and where no air class is set.

Lab cleanroom vs standard lab: pressure, air and particle limits

How a cleanroom lab differs from a standard lab in pressure, air changes and particle limits, with Cornell, FDA and EU Annex 1 values.

Cleanroom energy saving options: set-back, fans, filters and air volume

Five ways to cut cleanroom energy use, with UK HTM 03-01 set-back rules, FDA air change figures and a calculated fan power example.

Class 100, 1,000, 10,000 and 100,000 Cleanrooms Explained

What Class 100, 1,000, 10,000 and 100,000 cleanrooms mean, their ISO 14644-1 equivalents, particle limits per m³ and ft³, and what each class is used for.

How to Import a Cleanroom from China

Importing cleanroom panels, doors and equipment from China: choose the scope, check the factory, agree documents, payment, packing and customs code.

Cleanroom Door Installation: From Opening to Handover

How to install cleanroom doors in panel or block walls: when they go in, sizing the opening, fixing the frame flush, sealing, interlocks and checks.

The Cleanroom Project Lifecycle

Cleanroom project stages from brief and URS to design, build, testing, handover, monitoring and requalification, and who owns each step.

Injection Moulding Cleanrooms for Medical Device Parts

Planning an ISO 7 or ISO 8 cleanroom for injection moulding medical device parts: machine layout, heat load, part flow, gowning, pressure and what to send.

How to Choose a Cleanroom Panel Manufacturer in China

How to choose a cleanroom panel manufacturer in China: panel families, documents, certificates, factory checks, packing and installation support.

Hinged Cleanroom Doors in Brick, Block and Panel Partition Walls

Fitting hinged cleanroom doors in brick or block walls and panel partitions: what to measure, frame and seal details, swing and a quote checklist.

Paper Honeycomb Cleanroom Panels for Walls and Ceilings

Paper honeycomb core cleanroom panels for walls and ceilings: sizes, how humidity and fire affect paper cores, ceiling supports and what to ask first.