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. . . THE RELATIVE SIZE OF PARTICLES HUMAN HAIR SCALE FINE BEACH SAND 90gm SO•180gm GRAIN WHITE BLOOD CELL GRAIN OF POLLEN OUST PARTICLE (PM,.) RED BLOOD CELL RESPIRATORY OROPCETS • oust PARTICLE COAONAVJAVS • VIROS OF SALT 2Sgm 'Ogm.

[Audio] What I make at work.

. Minimum Apparel & Wipe Recommendations IS08 IS07 (Class 100,001 Classao,oom Beard Cover Face Mask Booties Coverall Gloves Hair Cover Hood Lab Coat Sealed Edge Wipes (Class 1,000) (Class 700) TSO 4 (Class 10}.

[Audio] Top-Down Donning Sequence 1.Start by washing your hands thoroughly. 2.Take a few steps over a tacky mat to remove excess dirt. 3.Don disposable booties ( shoe cover). 4.Apply bouffant ( beard covers for users with facial hair). 5.Apply face mask. Adjust the nosepiece to fit your face. 6.Remove coverall from cleanroom bag by holding the coverall inside the neck part. 7.Put on cleanroom gloves, gloves should be rolled over coverall sleeves. 8.You can now enter the gowning area by passing over the bench area (photo 1), and the Donning should look similar to photo 2. That completes our gowning procedure. Following these steps, each and every time will help prevent contamination inside the cleanroom. Photo 1 Photo 2 Cleanroom Procedure ISO 8.

[Audio] Handwashing procedure. . . Handwashing procedure.

[Audio] Inside the Cleanroom. . . Inside the Cleanroom.

[Audio] Standard ISO 8 There are several general requirements and environmental parameters to consider for an ISO 8 cleanroom, these include: 1. HEPA filtration 2. Air Changes per Hour (ACH) 3. Air pressure 4. Temperature and humidity 5. Amount of personnel working in the space 6. Static control 7. Lighting 8. Noise levels.

[Audio] Monitoring of air particles • In Boston Scientific we use a handheld Kanomax laser particle counter, this has the ability to measure three different particle sizes simultaneously - 0.3, 0.5, and 5.0µm. The 3887 measures in cf or m³ and displays all three particle size counts. The Kanomax laser particle counter includes software that allows users to download data to a computer for analysis..

[Audio] Why procedure needed • Quality can be defined as the ability to consistently procduce products meeting the same specification time after time. Products must be safe, pure, uniform and effective. Patient safety is the primary focus of any pharmaceutical medical device. This is the expectation of any patient or user. • Regulatory requirements are increasingly stringent throughout every step of a product's life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. FDA • The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation..

[Audio] Key Procedures Bioburden testing conducted monthly Endotoxin testing conducting 4 times week • What is the difference between bioburden and endotoxin testing? • The key difference between bioburden and endotoxin is that bioburden is the number of microorganisms found in a given amount of material before undergoing sterilization, while endotoxin is a type of toxin released by microorganisms to the surrounding environment. Cleaning & Disinfection Protocol for Cleanrooms • Isopropyl Alcohol is used on all surfaces and a log kept for record.

[Audio] Improvements • Standards need to be improved in relation to bringing laptops into an ISO 8 cleanroom, in particular Boston Scientific is very lax..

. . • Slide 3: https://bluethundertechnologies.com/cleanroom-clothing-requirements-and-selection-guide/.