openPR Logo
Press release

How to choose a cleanroom that meets FDA standards?

02-26-2025 06:28 PM CET | Associations & Organizations

Press release from: ABNewswire

1. Determine the cleanliness level and applicable standards

Choose the cleanliness level based on production needs: According to the control requirements of the production process for particles and microorganisms, refer to the ISO 14644 standard to determine the cleanliness level. For example, ISO Class 5 (Class 100) is suitable for high-precision pharmaceutical or biotechnology production, while ISO Class 7 (Class 10,000) may be used for medical device assembly.

FDA-related regulations: FDA requires clean rooms [https://www.dersionclean.com/] to comply with GMP (Good Manufacturing Practice), focusing on controlling microbial contamination, pressure difference, ventilation frequency, etc. For example, FDA stipulates that the pressure difference between adjacent clean areas must be at least 12.5 Pascals (Pa) to prevent cross-contamination.

Image: https://www.dersionclean.com/uploads/Cleanroom.jpg

2. Building materials and structural design

Material property requirements:

Smooth and dust-free surface: Melamine resin, color steel plate and other materials are preferred to avoid adsorption of particles and are easy to clean.

Anti-static and flame retardant: The material must have anti-static properties to reduce dust adsorption and meet fire protection standards (such as Class A flame retardant).

Airtight design: doors, windows and partitions need to be well sealed to prevent external pollutants from penetrating. For example, the automatic lifting seal strip at the bottom of the door can enhance airtightness.

Floor and wall: Epoxy self-leveling or PVC roll floor is recommended, which is seamlessly connected to the wall; the wall panels need to be sealed on all four sides to prevent the sandwich material from leaking out.

3. Pressure difference and airflow control

Positive and negative pressure design:

Positive pressure area: The core clean area needs to maintain positive pressure (such as greater than or equal to 12.5 Pa) to prevent pollutants from non-clean areas from entering.

Negative pressure area: Areas involving harmful substances (such as pathogens) need to maintain negative pressure to prevent internal pollutants from leaking out.

Dynamic and static pressure difference management:

Dynamic pressure difference: The pressure gradient inside and outside the clean room is maintained through the ventilation system to ensure reasonable air flow.

Static pressure difference: There must be a pressure gradient between areas of different clean levels, such as a step-by-step decrease from a high clean area to a low clean area.

4. Air filtration and sterilization system

High efficiency filter (HEPA/ULPA): A liquid tank sealed high efficiency filter must be used, and PAO (aerosol) test must be passed to ensure zero leakage. Class A clean areas require unidirectional flow (laminar flow) and uniform wind speed (0.45 m/s plus-minus 20%).

Air change frequency and self-cleaning capacity: The air change frequency is adjusted according to the cleanliness level. For example, the air change frequency of ISO 5 cleanrooms must be much higher than that of ISO 8. After production, it takes 15-20 minutes to self-clean to reach the static standard.

Disinfection measures: Use fast-evaporating cleaning agents such as isopropyl alcohol (IPA) combined with ultraviolet or ozone sterilization systems to control microorganisms.

5. Compliance verification and continuous maintenance

Documents and certifications: Material suppliers must provide ISO 9001 or ISO 13485 certification to ensure compliance with FDA and GMP standards.

Regular testing: Pressure differential monitoring, particle counting, microbial sampling and filter integrity testing are required, and data must be recorded for review.

Personnel training and process management: Establish strict dressing procedures (such as wearing anti-static clothing), material entry and exit procedures, and conduct regular audits to maintain compliance.

Example application scenarios

Pharmaceutical industry: Focus on microbial control, use Class A laminar flow hoods and negative pressure weighing equipment to ensure aseptic operation.

Electronic manufacturing: Focus on anti-static materials and particle control, and use low-dust materials such as aluminum honeycomb panels

Media Contact
Company Name: Kunshan Dersion Environmental Technology Co., Ltd.
Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=how-to-choose-a-cleanroom-that-meets-fda-standards]
Country: China
Website: https://www.dersionclean.com/

Legal Disclaimer: Information contained on this page is provided by an independent third-party content provider. ABNewswire makes no warranties or responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you are affiliated with this article or have any complaints or copyright issues related to this article and would like it to be removed, please contact retract@swscontact.com



This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release How to choose a cleanroom that meets FDA standards? here

News-ID: 3888655 • Views:

More Releases from ABNewswire

UK Taxpayers Searching for the Highest Rated Tax Software in 2025 Are Choosing Pie
UK Taxpayers Searching for the Highest Rated Tax Software in 2025 Are Choosing P …
Pie Money Limited is a UK-focused fintech company founded by Tommy Mcnally. Headquartered in Dublin, Pie's mission is to make tax simple, stress-free, and accessible. Its services include real-time tax projections, HMRC submissions, compliance support, and smart bookkeeping tools. Fully HMRC-compliant and trusted by thousands across the UK, Pie ensures taxpayers file with confidence and never miss what they're owed. BIRMINGHAM, United Kingdom - 3 September, 2025 - As more people
Author Sammy Jo Pendergrast Releases Expanded Second Edition of Bluestar
Author Sammy Jo Pendergrast Releases Expanded Second Edition of Bluestar
A reimagined sci-fi epic returns-Sammy Jo Pendergrast releases the definitive 2nd edition of Bluestar. Image: https://www.abnewswire.com/upload/2025/09/bd5cfaee54f726d44f767c0910049255.jpg Award-winning storyteller Sammy Jo Pendergrast invites readers back into a galaxy torn apart by war with the newly released second edition of Bluestar . This definitive version of the acclaimed space opera has been expanded by more than 200 pages, enhanced with original chapter artwork, and features a striking new cover design. Set in the aftermath of
Blackwell Captive Solutions Partners with Cygenex to Add Genetic Testing to B.Well Edge Portfolio
Blackwell Captive Solutions Partners with Cygenex to Add Genetic Testing to B.We …
New precision medicine capabilities help employers bend the healthcare cost curve through early risk detection. Blackwell Captive Solutions [https://blackwellcaptive.com/] today announced a new strategic partnership with Cygenex [https://www.cygenex.com/], a leader in advanced diagnostic testing and personalized preventive health solutions. Through this collaboration, Cygenex will become part of B.Well Edge, Blackwell's portfolio of best-in-class solutions designed to help employers proactively manage healthcare costs and improve outcomes. "B.Well Edge is about giving employers access
The Next Wave of Functional Flours - Chickpeas, Lentils, Beans & Beyond | A $110 Billion Market - Arizton
The Next Wave of Functional Flours - Chickpeas, Lentils, Beans & Beyond | A $110 …
Industry Analysis Report, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast 2025-2030. According to Arizton research, the global functional flour market [https://www.arizton.com/market-reports/functional-flour-market] was valued at USD 71.34 billion in 2024 and is expected to reach USD 110.93 billion by 2030, growing at a CAGR of 7.63% during the forecast period. The surge in legume-based flours is driving market growth, fueled by the rising demand for gluten-free products, growing

All 5 Releases


More Releases for ISO

Integrated Management System (IMS) Lead Auditor Training: Master ISO 9001, ISO 1 …
SIS Certifications Announces Comprehensive Integrated Management System Lead Auditor Training SIS Certifications announced its upcoming Integrated Management System (IMS) Lead Auditor Training program, designed to help professionals master the three most important ISO standards: ISO 9001:2015 (Quality Management System), ISO 14001:2015 (Environmental Management System), and ISO 45001:2018 (Occupational Health and Safety Management System). Know about Training - https://www.siscertifications.com/iso-training/ The six-day intensive training offers a flexible hybrid format, with both remote and onsite attendance
ISO Document Control Required by ISO 9001:2015
Image: https://www.getnews.info/uploads/1733971370.jpg The website for Endeavour Technical Limited provides dozens of manuals, descriptions, templates, and explanations for businesses striving to comply with ISO 9001. The procedures for document control are spelled out. Endeavour Technical Limited is pleased to announce that the procedures, templates, and explanations for ISO document control [https://www.iso-9001-checklist.co.uk/7.5.3-control-of-documented-information-explained.htm] are available for businesses of all sizes. ISO requires businesses to organize and collect necessary information about various processes. The information
NanoMatriX Technologies Receives ISO 27001, ISO 27701, ISO 27017, and ISO 27018 …
Hong Kong, February 4, 2024 - NanoMatriX Technologies Limited, a leading provider of secure document and product protection, authentication, and traceability solutions, proudly announces its achievement of ISO 27001:2022, ISO 27701:2019, ISO 27017:2015, and ISO 27018:2019 certifications from TUV SUD. This accomplishment reinforces NanoMatriX's commitment to delivering cyber-secure and data-protected solutions to its diverse clientele across 50+ countries. These globally recognized certifications emphasize NanoMatriX's adherence to the highest information security, cybersecurity,
Layer3 achieves ISO 27001 and ISO 27017 Certifications
Layer3, an industry leader in cloud, scalable and secure networks, has achieved the much-in-demand ISO/IEC 27001:2013 and ISO/IEC 27017:2015 certifications. ISO/IEC 27001:2013 is the most widely used information security standard, prepared and published by the International Organization for Standardization (ISO), the world’s largest developer of voluntary international standards. It is a globally recognized standard mandating numerous controls for the establishment, maintenance, and certification of an information security management system (ISMS). The
ISO Certification Market Report 2018: Segmentation by Type (ISO 9001:2015, ISO 2 …
Global ISO Certification market research report provides company profile for The British Standards Institution, CERTIFICATION EUROPE, NQA, Lakshy Management Consultant, URS Holdings, Bureau Veritas, DNV GL AS (International Standards Certifications Global FZ), SGS, Lloyd's Register Group Services, Intertek and Others. This market study includes data about consumer perspective, comprehensive analysis, statistics, market share, company performances (Stocks), historical analysis 2012 to 2017, market forecast 2018 to 2025 in terms of volume,
ISO 27001/ISO 27002 Consultancy,ISO 27000,ISO 27000 Consultancy,Information Secu …
Coralesecure is a Information Security Management System (ISMS) – ISO 27001 Compliance. ISO 27000 Consultancy deals with maintaining the integrity and availability of organizational information and knowledge. Information Security Management System provides the experts on business management, and information security support and properly engages in executive communications Data loss, whether through cyber attacks or other forms of malicious intent can quickly bring an organization to its knees? The protection of