clean room standards - iso 14644 guidelines by operon strategist

1. ISO 14644 Standard – Why is it necessary for your Clean Room? Call / Whatsapp - 9325283428 www.operonstrategist.com

2. So you are looking for ISO 14644 for a clean room! • If you are into the medical industry, or if your work nature is into the commercial, medical or industrial industry, then you should know about the Clean Room, where every medical industry must work under “clean” conditions, as an extremely small dust particle or off-gassing can make the entire batch of medicines unusable. A clean room is a very important part of every medical manufacturing process. A company also needs a dust-free clean room to conduct tests and accelerate the innovation process before manufacturing begins. The main purpose of cleanroom is for product yield and improving quality control in an environment by the limited presence of sub-micron particles within the clean room, and also provides the employee’s safety. Call / Whatsapp - 9325283428 www.operonstrategist.com

3. What is a Clean room? • ‘A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, eg temperature, humidity, and pressure are controlled as necessary.’ Call / Whatsapp - 9325283428 www.operonstrategist.com

4. Clean room Manufacturing as per ISO 14644 standard • How clean the room is measured and how can it be determined? We will explain to you in this blog article. Clean room are controlled areas that are classified by how clean the air is, according to the quantity and size of particles per volume of air. • Clean room design and development requires tight controls over contamination, air flow rate, pressure, temperature, and humidity. To manufacture the clean room ISO class system provides an industry-wide standard that is ISO 14644 it’s the clean room standard for cleanliness and particles counts. • ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in clean rooms and clean zones; and separative devices as defined in ISO 14644‑7. Call / Whatsapp - 9325283428 www.operonstrategist.com

5. ISO 14644 is composed of: • Part 1: Classification of air cleanliness by particle concentration • Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration • Part 3: Test methods • Part 4: Design, construction, and start-up • Part 5: Operations • Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) • Part 8: Classification of air cleanliness by chemical concentration (ACC) • Part 9: Classification of surface cleanliness by particle concentration • Part 10: Classification of surface cleanliness by chemical concentration Call / Whatsapp - 9325283428 www.operonstrategist.com

6. Here are some significant changes introduced in ISO 14644-1 from different perspectives: • ISO Classification Table • Minimum Required Number of Sample Locations • UCL 95% • Equipment Calibration • Ultra and Micro Descriptors • Sequential Sampling • Amendments to the method of evaluation of data collected from airborne particle counting • The basic ISO cleanliness classes 1 to 9 do not fundamentally change, but the classification process requires the adoption of a revised protocol for every clean room or clean air device • The revised standards also include updated references to normative and supporting standards Call / Whatsapp - 9325283428 www.operonstrategist.com

7. Thank You.For More Information Contact Uswww.operonstrategist.cominfo@operonstrategist.com+91-9325283428 Call / Whatsapp - 9325283428 www.operonstrategist.com