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1. Leave personal items outside the controlled environment

If any important items need to be brought into the cleanroom for any reason make sure they are concealed beneath appropriate cleanroom garments.

2. No consuming food or smoking inside the cleanroom

3. Do not wear makeup and perfume --> unnecessary contaminants

4. Do not run or move more quickly than necessary within the controlled environment--> stir up particulate and lead to an increase in the contamination of products.

5. Do not enter the cleanroom if you’re sick --> germs

6. Adhere to proper gowning and ungowning procedures

7. Practice good personal hygiene

8. Cover hair and facial hair

9. Do not smoke before entering the cleanroom-->allow the residual smoke to leave your clothing and skin.

10. Do not sit or lean on equipment or work surfaces --> transfer any contaminants between the two.

11. Do not touch your face or hair with gloved hands

--> If you need to tuck your hair or scratch an itch, exit the cleanroom and replace your gloves before re-entering.

Why is cleanroom protocol required ?

--> humans shed and produce contaminants

e.g. flakes of skin,oil, sweat, and hair

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Cleanroom environments are unlike any other. They come with challenges and requirements specific to their construction, classification, and purpose. Not only do you and your cleaning crew need to have a thorough understanding of the regulations specific to the controlled environment, but so does everyone who enters the room. You need to establish a clear set of rules to limit the amount of particulate in the room, the disruption of particles, and general contamination.

Cleanroom Environment Protocols:

1. Leave personal items outside the controlled environment

If items such as keys, wallets, phones, etc. must be brought into the cleanroom for any reason, ensure they stay concealed beneath appropriate cleanroom garments.

2. Do not eat, smoke, or chew gum inside the cleanroom

3. Do not enter the cleanroom if you're unwell
Germs and other issues associated with physical illness should not be allowed within the cleanroom environment.

4. Don't let anyone enter the cleanroom if they aren't appropriately covered, with clean and gloved hands, face masks, covered shoes, safety glasses, etc.

5. Do not touch your face or hair with gloved hands If you need to tuck some hair under your bouffant or scratch an itch, properly exit the cleanroom to do so and replace your gloves before re-entering.

Why You Need a Cleanroom Protocol

People naturally produce contaminants. Flakes of skin, oils, sweat, and hair are all contaminants within the cleanroom environment and precautions must be taken to limit their reach. Human behavior also has a massive effect on the cleanliness of the cleanroom. Moving too quickly and sneezing or coughing in a controlled env ironment puts the entire environment at risk.

The above list is limited to what those who enter the cleanroom environment should and should not do once inside, but it is by no means an exhaustive list of all cleanroom guidelines and regulations. Simply following this list will help control contaminants in the cleanroom, but it will not actually clean the cleanroom.

Need to get started with a thorough Cleanroom Cleaning process? Get your instant quote today.

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11 Rules to Follow in Your Cleanroom Environment

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Everyone who enters your cleanroom environment needs to follow these protocols to limit the amount of contamination.

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I found it difficult to understand the process of cleaning the BSC. In previous modules, I was taught only to spray the towel with ethanol and wipe in circles. However, after watching this video, I was able to understand better sanitising techniques to clean the BSC and other equipment. For equipment that are difficult to access, etc bioreactor pipes, spraying is recommended instead of wiping.

Paper towels should be used to wipe in only one direction. Another side of the towel should be used after one wipe for a total of 8 sides per towel.

When spraying, we should spray from top to bottom and back to front, pools should also be avoided.

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i was confused about the airlock rooms we have to enter before actually entering the clean room (L5). but from this video, i can see clearly how the airlock works and how it is able to prevent undesired pathogen from entering the clean room

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Passing through sterile disinfection into cleanrooms

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High in maintenance

fixed in place

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To clean and disinfect clean room floors:

Use a single-use mop with a prepared cleaner

- Start at the corner of the room, furthest from the entry way moving the damp mop using the place and pull method and overlapping strokes, cover about one square meter before rewetting the mop

- Continue this whole process across the entire floor working your way out of the room, making sure not to step on any areas which have been cleaned/cleared

Another method that is commonly used to clean the floors is the s-curve method

- Start at the corner furthest from the entryway

- With a damp mop, make your first pass along the wall edge begin the s-curve by walking backwards moving the mop in an S shape using overlapping strokes

- Make sure to maintain one leading edge throughout the process at this point

- Follow the same procedure using the facility's disinfectant

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https://youtu.be/MMHW61Mgcj4?si=rK6I4oV3OsPslN6u

GMP also known as Good Manufacturing Practices are key to main cleanliness and sterility in cleanroom.

GMP of cleaning and disinfecting clean rooms are

1. cleaning agents

use cleaning agents approved for clean room

use non shedding, low residue and non toxic materials

2. cleaning procedures

follow documented cleaning procedures such as wiping surfaces and moping floor to prevent contamination

3. validation and monitoring

regularly validate and monitor cleaning and disinfection process through swab testing, air monitoring, and visual inspection

4. documentation and records

maintain records of cleaning schedule

record disinfection used

record any deviation from the standard procedure

5. risk assessment

regularly conduct risk assessments to identify potential source of contamination and take corrective actions to mitigate these risks.

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The GMP of Cleaning & Disinfecting Cleanrooms