A Vital Connection Between Contamination Control and Product Quality

The idea of contamination control goes beyond removing microbes and contamination from cleanroom surfaces and tools. It is a comprehensive procedure that aims to control the existence, growth, and proliferation of contamination the areas such as cleanrooms.

The core goal of contamination control is to provide and maintain sufficient levels of cleanliness in controlled environments. Cleanroom contamination control requires the implementation of various preventive procedures, including strict clothing rules, ISO-certified cleanroom packaging, gowning rooms, cleaning agents, etc.

Contamination control is an essential procedure for labs in the life science and pharmaceutical sectors, automotive paint shops, industrial kitchens, and any industry whose product manufacturing must be done within a cleanroom. Besides, contamination control protocols are conducted to combat potential pandemics or biohazards.

What is a Cleanroom?

A cleanroom is an environment in which the amounts of airborne particles are highly controlled. Its purpose is to minimize the introduction, accumulation, and retention of particles inside the area, which is achieved through the right temperature, humidity, and pressure.

Cleanrooms are commonly used for product packing, manufacturing, and assembling. The room removes airborne contamination coming from people, surfaces, and equipment. The higher the levels of cleanliness, the lower the chances of microbes damaging your products.

A Lack of Contamination Prevention Procedures and Its Consequences

Contamination prevention procedures are required in some environments because contamination may affect product manufacturing, technical processes, and experiments. Substantial amounts of airborne particles and contaminants may damage the product, directly impacting your business and the quality of service you provide to your customers.

What Causes Contamination?

Many factors may cause contamination, including, but not limited to:

• Human hair and particles from the body, clothes, and poor hygiene often lead to the accumulation of microorganisms.
• Contaminated air, dust particles, work surfaces, ceilings, walls, and floors may increase the contamination levels inside the indoor area.
• Deposition of microorganisms on the packaging, and the packaging itself, tends to create particles and dust.
• Dirty equipment poses a significant risk to environments that should maintain controlled contamination levels.
• Since most microorganisms grow in water, any spills that are not mopped adequately or equipment left in a damp condition may lead to contamination.

Clean Room Contamination Control Step-by-Step

Body movements, equipment, floors, and ceilings that are inadequately protected may spread contaminants and potentially affect the products like computer chips, medical equipment, or pharmaceutical products.

1.      Use Cleanroom Packaging to Prevent Product Contamination

Even if your product is manufactured in a highly controlled environment, all your effort may be in vain if its packaging doesn’t meet the requirements set by ISO or FDA. Cleanroom packaging forms an essential part of any cleanroom environment as it protects your product from pollutants and airborne particles while entering or leaving the cleanroom.

Cleanroom packaging is required in industries such as pharmaceutical and healthcare, aerospace, life sciences, biotech, and any facility that produces computer chips or electronic components.

Most cleanroom bags offer a barrier that prevents moisture or oxygen from interfering with your product. That way, the quality of your product won’t be affected, but it will remain functional and contaminant-free.

Cleanroom packaging comes in various sizes, shapes, and materials suitable for different industries and their purposes. The most common cleanroom package types include:

• High-density poly cleanroom (HDPE) bags. HDPE bags have excellent temperature resistance and exceptional non-scratch, moisture- and puncture-resistance properties. Therefore, they are suitable for storing hot/cold items, optical lenses, and similar objects.
• Low-density poly (LDPE) bags. LDPE bags are the most versatile cleanroom packaging for contamination control. They are strong and moisture-resistant but cannot withstand extreme temperatures like HDPE bags.
• Nylon cleanroom bags. Nylon bags are the best heat-sealable solution with increased oxygen and moisture transmission resistance. It makes them suitable for electronics, pharmaceutical products, and precision components. In addition, nylon remains stable during and after gamma irradiation.
• Moisture-barrier film. As its name suggests, a moisture-barrier film is used in products requiring the utmost protection from moisture vapor and oxygen transmission. Additionally, it ensures your product remains fresh and functional longer.
• Cleanroom poly tubing. If individually cut bags are not suitable for your products, you should consider cleanroom poly tubing. It is excellent for items that are long or when you need to package the same product continually.
• Cleanroom ziplock bags. Zipper poly bags are a practical choice since they allow technicians to open the bag with gloves on and without sharp objects such as knives or blades.

2.      Provide Adequate Air Filtration System for Air Contamination Control

Cleanrooms are designed to reduce the presence of unwanted particles, which is mostly achieved through special HEPA (High-Efficiency Particulate Air) filters. HEPA filtration systems can remove up to 99.97% of bacteria, mold, dust, and airborne particles with a 0.3 microns size.

HEPA filters are quintessential to prevent contamination and provide consistent airflow inside a cleanroom. However, you and your staff must be careful not to do the following actions:

• Block HEPA-filtered air from reaching your products with your body or equipment
• Tape sheets on walls or laminar flow tables to avoid blocking HEPA filter air
• Turn off the HEPA filter.

3.      Conduct Regular Cleanroom Cleaning

To set up and maintain a cleanroom, you will need products specifically designed for cleanroom use. For instance:

Cleaning Equipment

Cleanroom cleaning equipment includes anything from a special vacuum cleaner with HEPA filter to cleanroom mops, buckets, detergents, and more. You must ensure all the cleanroom surfaces, including walls and floors, are clean and disinfected at any time.

Consumables

Special cleanroom wipes are excellent for cleaning small cleanroom surfaces. You should always have them on hand in case of accidental spills or a smaller mess that needs to be addressed immediately. Unlike regular wipers, those used in a cleanroom have better cleaning properties, lower lint levels, better absorbency, chemical- and abrasion-resistance, and other features that ensure a complete contamination control.

Aside from cleanroom wipers, you should place adhesive mats at cleanroom entrances to ensure no pollutants from shoes can enter a highly controlled space. Additionally, make sure you’re using specific cleanroom paper made without organic fillers that lower the risk of particle generation.

Cleanroom Apparel

Adequate cleanroom apparel is exceptionally important because street clothes may bring substantial amounts of contaminants into the cleanroom. Depending on the cleanroom’s classification and specific requirements, you will need more or less cleanroom clothing. The most commonly used garments include face masks, beard covers, hairnets, gloves, boot covers, etc.

Cleanroom Furniture

All the furniture inside the cleanroom, including worktables, stools, and chairs, must be designed for bioscience, pharmaceutical, semiconductor, and similar applications.

Controlling contamination is a comprehensive task one must complete to ensure a safe and particle-free environment for your products. Here are some important tips to keep your controlled environment clean:

• Don’t use non-cleanroom specified cleaning agents
• Use deionized (DI) water to scrub all surfaces, floors, benches, and walls
• Avoid scrubs, powders, or rags in the cleanroom. Instead, use cleanroom mops
• Use an autoclave-ready multi-bucket mopping system
• Vacuum walls and ceilings every day
• Change sticky cleanroom mats regularly.

4.      Wash Your Hands Thoroughly Before Entering the Cleanroom

Although wearing gloves in the cleanroom is mandatory, you should not forget to wash your hands prior to putting gloves on. Poor hand hygiene may increase the risk of bacteria and the potential onset of viruses and fungus.

Any clean room protocol requires you to wash your hands thoroughly to prevent contamination. Here are some tips on how to wash your hands in a cleanroom:

• Wet your hands with water and then apply soap
• Use HEPA-equipped hand dryers instead of paper towels
• Cover all your hand surfaces and scrub for at least 15 seconds
• Do not touch clean garments unless you’ve washed your hands
• Avoid adding soap to a partially full soap dispenser.

5.      Follow Gowning and Gloving Clean Room Procedures

Wearing sterile gloves and protective cleanroom garments is a critical part of a clean room protocol. When it comes to cleanroom clothing, it is essential to wear them in the correct order to ensure no particles or contaminants could pass from your body to the product you’re manufacturing. Here are some tips to ensure you’re following the guidelines correctly:

The gowning clean room procedure may vary from industry to industry, meaning that some may require more or fewer garments. Sometimes, facilities may require you to wear dedicated cleanroom shoes or shoe covers, while some cases (hazardous rooms) require two pairs of shoe covers for complete contamination control.

When it comes to donning gloves, avoid doing the following:

• Wear jewelry, nail polish, or any cosmetics
• Wave gloved hands to encourage faster drying after applying the alcohol solution
• Touch exposed skin with a gloved hand.

Instead, focus on the following:

• Use sterile gloves instead of the powdered ones
• Dry hands completely before putting the gloves on
• Put the glove on the dominant hand first
• Use wall-mount consumable dispenser for less movement and easier access.