Name: PowerPoint Presentation
Uploaded: 2022-04-24
Duration: 6 min 14 s
Description: . . . 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.

. . . 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. 

Scene 1

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

Scene 2

. 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}. 

Scene 3

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. 

Scene 4

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.

[Audio] Handwashing procedure. . . Handwashing procedure. 

Scene 5

Hand-washing technique with soap and water
Wet hands wat«
back of each hand
wim palm ot oth« hand
With
7
Rub each thun& clasc»d
using a
rnovement
Dry with
a single-use towel
2
to
hand surface
Rub to
8
Rub of fingers in
pdm a
m oticm
to turn off t..x:.t
3
hands to
6
Rub with back Of fingers
to opposing 'W•ns with
fingers
9
Rinse hmds
12
15-30 seconds

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

Scene 6

[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. 

Scene 7

th
PL
spa
FRESH AIR
RETURN AIR VIA LOW LEVEL GRILLES

There are several general requirements and environmental parameters to consider for an ISO 8 cleanroom, these 
include:

5.
Amount of personnel working in the space

[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.. 

Scene 8

• 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

[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.. 

Scene 9

• 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.

• 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. 

Scene 10

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.. 

Scene 11

• 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/. 

Scene 12

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

• Slide 4 https://balcontab.com/blog/cleanroom-gowning-procedures/,

https://www.palbamclass.com/product/Modular-Step-Over-Bench and https://www.laboratory-
supply.net/blog/cleanroom-gowning-procedure/

• Slide 6: https://www.clearsphere.com/cleanroom-laboratory-products.htm and

https://www.startribune.com/boston-scientific-profit-tops-estimates-shares-soar/216920331/

• Slide 9: https://www.differencebetween.com/what-is-the-difference-between-bioburden-and-endotoxin/

• https://www.instrumart.com/products/32130/kanomax-3887-laser-particle-counter

PowerPoint Presentation

Scene 0

avatar

1.Start by washing your hands thoroughly.

2.Take a few steps over a tacky mat to remove excess  dirt.

4.Apply bouffant (beard covers for users with facial  hair).

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.

Following  these steps, each and every time will help prevent  contamination inside the cleanroom.

There are several general requirements and environmental parameters to consider for an ISO 8 cleanroom, these  include:

• 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.

• 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.

• 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.

• 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.

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