اتاق تمیز

WHO NEEDS A CLEANROOM

/در , /توسط

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out in order to provide the cleanest area possible. Most cleanrooms are used for manufacturing products such as electronics, pharmaceutical products, and medical equipment. A cleanroom can be classified into different levels of contamination depending on the amount of particles allowed in the space, per cubic meter. Cleanrooms also control variables like temperature, air flow, and humidity.

HOW DOES A CLEANROOM WORK?

Essentially, cleanrooms work to remove pollutants, particles, and contaminants from outside ambient air. Outside air is first circulated to a filter system. The filters (either HEPA or ULPA) then clean and decontaminate this outside air according to their specifications. The filtered air is then forced into the cleanroom. Additionally, contaminated air within the cleanroom is forced outside the room by registers, or it is recirculated back into the filters, and the process restarts.

WHO NEEDS A CLEANROOM?

There are a wide variety of reasons that a company may need a cleanroom. If you’re manufacturing something that is easily affected by contaminants or particles in the air for example, it’s likely that you’ll need a cleanroom. If you’re not sure, or if you’d like an estimate, give the experts at Angstrom a call. Here are a few common reasons you might need a cleanroom, and some common industries that regularly use cleanrooms:

  • Manufacturing Companies
  • Research Facilities
  • Pharmaceutical Companies
  • Medical Laboratories
  • Electronic Part Production
  • Aerospace Industry
  • Nanotechnology production
  • Optics and Lens Manufacturing
  • Military Applications

HOW DO YOU KEEP A CLEANROOM CLEAN?

It can be difficult to maintain the standards of a cleanroom. The rooms themselves can be touchy, and everything you bring into the cleanroom is likely to release particles into the air, even your employees. So, what are the best ways to keep your cleanroom up to the standards you so painstakingly maintained? Here’s a few basic concepts, and some helpful suggestions to maintaining the highest level of clean in your cleanroom.

Gowning: First and foremost, anyone who enters the cleanroom has to be wearing protective clothing. Human beings are full of particles: our hair falls out, our skin flakes, and there’s no way to control it. That’s why it’s essential that anyone going into the cleanroom wear the prescribed protective clothing. Depending on your class of cleanroom, this might just be a gown and gloves, or it could be a full head to toe “bunny suit” complete with a mask and goggles. You first have to define your standards, but then you should know exactly what your employees should be wearing into the cleanroom.

Cleanroom Furniture: Believe it or not, furniture gives off particles even when it’s just sitting there. That’s why special cleanroom furniture is manufactured to lessen the particles and dust that fall and collect on furniture. It’s a good idea to invest in this type of furniture if you’re interested in keeping your cleanroom clean.

Air Shower: If you’re concerned with limiting the amount of particles brought into your cleanroom, you might consider investing in an air shower. Used in conjunction with the gowning room, it blows off any particles that could easily fall off people entering the cleanroom. It’s a great way to eliminate any extra particles before your employees enter the cleanroom.

Sticky Flooring: This is the best way to take care of foot-borne or wheel-borne contaminates. Better than sticky mats, sticky flooring is more durable, more effective, and can last for 3-5 years, if properly cleaned and taken care of. If your cleanroom has a high standard for cleanliness, this is a useful addition to your cleanroom.

PROPER GOWNING TECHNIQUES

The cleanroom gowning process may seem like a hassle, but you spend a lot of money getting the cleanroom installed and maintained, so a few extra minutes gowning properly isn’t a big deal if you’re protecting that asset and keeping your cleanroom as clean as possible. But what, exactly, do you have to do to make sure you and your employees are following proper protocol, and protecting the environment of the cleanroom? It starts with a standard procedure. It will be much simpler if everyone follows the exact same process, and understands the different areas of the gowning space. Generally, most gowning spaces have a “getting dressed” area and a “cleaner” area. Make sure employees understand these boundaries, and know where to stand at what point in the gowning process. Here’s an example of a standard gowning process. Remember, however, that most gowning processes will vary depending on the standard you’re required to adhere to.

Perfume and Cosmetics – If you’re working in a cleanroom, the gowning process starts before you even get to work. It’s important to remember that products like perfume, make-up, hair gels, etc. give off extra fumes and particles. To keep your cleanroom as clean as possible, it’s necessary that anyone entering the room not wear these types of products.

Remove personal items – Personal items like jewelry also have to come off before you go into your cleanroom. They, just like cosmetics, release extra, unnecessary particles into the air that you’re better off without.

Change Shoes – Shoes pick up all kinds of dirt and dust when you walk around. It’s a good idea to change your shoes once you walk into the building, and then as you enter the gowning area, make sure you step on a sticky mat to remove any excess particles.

Enter Gowning Area – Now you’ll enter the gowning room, and most places have a “getting dressed” area, which is where you’ll start. Make sure to put on a set of “donning gloves” or just a first set of gloves to eliminate particle contamination of gowning clothes. When gowning, remember to dress from head to toe; this eliminates particles from falling onto already gowned parts like coveralls and booties.

Don Bouffant – First, you’ll put on your bouffant, or hair cover. Make sure to only touch the inside of it, and before you move on, ensure that all hair is covered and out of the way. After this, you may also have to don a hood, depending on your cleanroom’s standards.

Don Coverall – If your coverall is one piece, start with the feet and move upwards. If it’s two pieces, start with the top and then sit down to put on the bottom half. Do not let the coverall touch the floor or walls. Make sure you zip all zips, and snap all snaps.

Booties or Shoe Covers – Now, sit on the bench to don booties or shoe covers. Make sure you tuck your pants into the booties or shoe covers, and don’t step in the “getting dressed’ area. Instead, step into the “cleaner” area of the gowning room. If your cleanroom has an automatic shoe cover dispenser, use that for cleanliest practice.

Don Goggles or Shield – If your cleanroom requires them, this is where you put on your goggles or face shield. Some cleanrooms do not require this level of protection, so you may be able to skip this step.

Final Pair of Gloves – Depending on protocol, you may now remove the first pair of gloves and put on a second, or you may put a second pair of gloves over the first. Roll the cuff of the gloves over top of your sleeves.

Enter – Now that you’ve properly gowned, you may enter the cleanroom. Remember that at this point you are as “clean” as you’re going to get, so if you touch anything before you get inside of the cleanroom, you’ll have to start over, or at the very least change your gloves.

If you have anymore questions regarding the information provided above, please reach out to one of our experts. The experienced experts at Angstrom Technology can answer any of your questions quickly and efficiently, and would love to hear from you!

Cleanroom Microbiology Identifying Sources Of Contamination

/در , /توسط

Microbial control is (Cleanroom Microbiology) critical in cleanroom environments. Cleanroom Microbiology.

Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects. Part 1 of this article provides an introduction to cleanroom microbiology, discussion of guidance documents and FDA observations, and a summary of common sources of microbial contamination in cleanrooms. Subsequent parts will address some cleanroom design basics, discussion of proper material transfer, aspects of cleanroom gowning, concepts of environmental monitoring, and the importance of disinfectant efficacy and proper cleaning.

An Introduction To Cleanroom Microbiology

Cleanroom microbiology encompasses a wide variety of subjects, including microbial identification, cleanroom design, material transfer, personnel and material flow, cleanroom gowning, personnel behavior, aseptic technique, environmental monitoring, data trending, cleaning, sanitization, and disinfection. Understanding the concepts of cleanroom microbiology is important to help control the cleanroom environment and ultimately ensure the consumer is safe.

Tainted environments or materials can potentially contaminate the product, lead to product recalls, regulatory observations, or fines, harm the product efficacy, or even kill the patient. A well-known example of this is the New England Compounding Pharmacy meningitis outbreak of 2012. More than 800 people were sickened and 64 people died due to product contaminated with fungus.1

Microorganisms are present in most habitats. This includes soil, water, plants, animals, hot springs, the deep sea, food, beverages, skin, and hair. To be able to survive in harsh habitats, certain species of microorganisms must be resilient. In fact, 25-million-year-old bacterial spores have been revived from the belly of a honey bee that was preserved in amber.2

Not only are microorganisms resilient, they are also easy to spread. They can be transferred directly from one surface to another by touching the surface with an object that is contaminated with microorganisms.3 Or, microorganisms can be transferred indirectly, such as when microorganisms are distributed through the air.3 In cleanroom environments in particular, humans are the primary source of contamination. Typically, 80 to 90 percent of normal microbial flora identified in a cleanroom environment is generated from humans.

Particular practices

Particular practices and procedures must be followed in order to minimize and control microbial contamination in the cleanroom environment. One of these practices is widely known as aseptic technique, a practice used to maintain sterility and prevent the spread of contamination.5 Some aspects of aseptic technique include: Cleanroom Microbiology

  • Never breaking first air or reaching over exposed product, components, or fill lines.
  • Not touching sterile items with nonsterile items.
  • Not exposing sterile items to nonsterile environments.
  • Using sterile components and gloves.

In order to control microbial contamination, all activities that happen in the cleanroom need to be controlled.

  • Processes should be demonstrated and validated to be successful.6
  • Procedures should be controlled and precisely followed.
  • Personnel should be properly trained, have good hygiene, attitudes, and behaviors, gown appropriately, follow procedures, practice good aseptic technique, move slowly and deliberately in the cleanroom, and do the right thing even when no one is watching.6
  • Raw materials and components should pass quality control testing prior to use in manufacturing. They should not add microbial contamination to the process.6
  • The facility and equipment should be properly maintained, cleaned, and disinfected.6
  • The facility should be constructed with quality by design concepts in mind and be fit for the manufacturing purpose.
  • Cleanrooms should have proper positive pressure air cascades and high-efficiency particulate air (HEPA) filtration.6
  • The environment and utilities must be properly maintained, monitored, and controlled to prevent the ingress of microorganisms, correct any microbial excursions, and prevent cross contamination.6

Guidance Documents And Regulatory Observations

There are multiple guidance documents and regulations that speak to cleanroom microbiology, including those on the following list. This is not intended to be all-inclusive.

  • European Commission EudraLex “The Rules Governing Medicinal Products in the European Union” Volume 4, EU Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II: Basic Requirements for Active Substances used as Starting Materials. Brussels, 03Feb2010
  • European Commission EudraLex “The Rules Governing Medicinal Products in the European Union” Volume 4, EU Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1 – Manufacture of Sterile Medicinal Products, 25Nov08.
  • FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. September 2004.
  • Parenteral Drug Association (PDA) Technical Report (TR) No. 13 – Fundamentals of an Environmental Monitoring Program
  • PDA Technical Report No. 69 – Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations
  • PDA Technical Report No. 70 – Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
  • Pharmaceutical Microbiology Manual (PMM) 2014, Version 1.1, ORA. 007, 25Apr14.
  • Pharmaceutical Inspection Convention (PIC/S) PI 007-6 “Recommendation on the Validation of Aseptic Processes” January 2011
  • United States Pharmacopeia (USP) <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
  • USP <1072> Disinfectants and Antiseptics

  • Code of Federal Regulations (CFR) Title 21, Volume 8. Cite 21 CFR 820.70 – Production and Process Controls.

    • 21 CFR 211.42
    • 21 CFR 211.25
    • 21 CFR 211.28
    • 21 CFR 211.113
    • 21 CFR 211.25
    • 21 CFR 211.28

When regulatory expectations are not met, warning letters may follow. Warning letters can be researched on the FDA’s website (https://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm). They can be a useful audit tool to help companies find, correct, and prevent similar findings. The following three summaries of FDA warning letters pertain to cleanroom microbiology. There are many more complete warning letters for review on the FDA website. Cleanroom Microbiology

FDA warning letter

  • The first summary is from an FDA warning letter that was written in July of 2014. During this inspection, the FDA noted insanitary conditions. The company violated cleanroom microbiology principles as follows:

    • The employees were not properly sanitizing their hands after touching nonsterile equipment.
    • The employees were wearing nonsterile masks.
    • The employees had exposed skin in the cleanroom.
    • The employees were reusing cleanroom gowning.
    • The company also did not perform personnel monitoring of all operators as required.
  • The second FDA warning letter was also written in July 2014. The FDA observed some cGMP violations during an inspection. Specifically, the FDA observed personnel not wearing clothing appropriate to protect drug product from contamination. This was a 21 CFR 211.28 violation.

  • The third FDA warning letter was written in February 2012. According to the FDA, the firm that received the letter violated cleanroom microbiology principles in the following ways:

    • The employees were using poor aseptic gowning technique.
    • The employees touched the outsides of the gowns while gowning.
    • The employees exposed equipment to a dirtier classification of air before introduction to the cleaner classification of air.
    • The employees broke first air during manufacturing.
    • The employees kept touching the parts of the filling machine.

Reading these warning letters, one can infer the following principles are key to maintaining a cleanroom environment:

  • The outside of the gowns must not be touched.
  • First air should never be broken.
  • Equipment should not be exposed to a dirtier classification of air prior to introduction to the cleaner classification of air.
  • Hands should be sanitized properly.
  • Sterile components should be worn.
  • Sterile gowning supplies should not be reused.
  • Skin should not be exposed.
  • منابع آلودگی در اتاق تمیز

Sources Of Microbial Contamination In Cleanroom Microbiology

Understanding the sources of contamination can aid in developing corrective and preventive actions when excursions occur. Microorganisms are easily spread and are practically everywhere.

Microorganisms can be classified based on their mode of mobility, their shape, their atmospheric needs, their Gram stain reaction, their optimal growth temperatures, and whether they produce spores. With regard to shape, microorganisms can be round (cocci), rod shaped (bacilli), spiral shaped, or even vibrio shaped, which looks similar to a comma.

The atmospheric needs of microorganisms will vary depending on the microorganism. Microorganisms can be aerobic, meaning they require oxygen to grow. They can be anaerobic, meaning they do not require oxygen to grow. Some microorganisms may require various other combinations of atmospheric conditions for cell growth.

Microorganisms also vary in their optimal growth temperatures. For example, psychrophiles enjoy colder temperatures, usually below 15 C.7 Mesophiles enjoy moderate temperatures, typically 20 to 45 C.7 Thermophiles like hotter temperatures, usually 45° to 80° C.7 If the cleanroom is kept at a moderate room temperature, the recovered microbial flora is usually mesophilic bacteria.

A Gram stain helps to determine the structure of the outer cell wall of bacteria. Most bacteria will fall into one of two groups as a result of the reaction to the Gram stain. Gram negative cells are pink and have a thin peptidoglycan cell wall, which is surrounded by an outer membrane containing lipopolysaccharide.7 When Gram negative rods are recovered in cleanrooms, sources of stagnant water or moisture are usually present. Gram negative bacteria can be found in water systems, on surfaces due to improper disinfection practices, in standing water, in piping or hoses with moisture, and in sinks or drains. Depending on the species, Gram negative rods may also originate from human, animal, plant, or food sources. Poor aseptic technique can contribute to spreading the contamination. Cleanroom Microbiology

Gram negative bacteria

Gram negative bacteria are also of the main source of endotoxin. Endotoxins are a complex lipopolysaccharide molecule located in the outer membrane of Gram negative bacteria.7 They are released when the bacterial cell is destroyed. This is a concern because endotoxins can trigger fevers, shock, or even death in the patient.

Gram positive cells are purple. They are surrounded by thick layers of peptidoglycan, but lack the outer cell membrane.7 Gram positive cells are the most recovered microorganisms in cleanrooms. They are usually associated with humans and are found on skin, hair, and clothing. Poor aseptic technique, poor material transfer practices, poor disinfection practices, and improper gowning can lead to contamination with Gram positive cocci microorganisms.

In cleanrooms, the phrase “Gram positive rod” typically sparks thoughts of contamination from dirt or soil. Gram positive rods are often isolated from dirt, soil, dust, air, cardboard, paper, water sources, mops, humans, food, and clothing. Gram positive rod microorganisms can either be spore formers or non-spore formers. Spores make bacteria harder to kill by allowing the bacteria to survive extreme habitat fluctuations. For example, the bacterium Geobacillus stearothermophilus is commonly used in autoclaves and isolator qualifications because of its resistance to heat and vaporized hydrogen peroxide. Poor aseptic technique, poor material transfer practices, poor disinfection practices, and improper gowning can lead to contamination with Gram positive rod microorganisms.

Yeasts usually appear to be very large oval cells under the microscope. When isolated from clean rooms, common sources of contamination are humans or food items. Poor aseptic technique, poor material transfer practices, poor disinfection practices, improper cleaning, and improper gowning can lead to contamination with yeast.

منابع آلودگی در اتاق تمیز

 

 

 

 

 

 

 

 

Molds can grow almost anywhere and are typically found in damp, dark, and humid areas. When molds are isolated in cleanrooms, paper, cardboard, wet drywall, heating, ventilation, and air conditioning (HVAC) systems, or wooden pallets are the typical sources of contamination.8 They are also associated with the building, walls, ceilings, dirt, and even dust. Improper disinfection practices, improper cleaning, poor material transfer practices, poor gowning practices, or improper aseptic technique can lead to contamination with mold.

The next article in this series reviews the basics of cleanroom design and best practices for proper material transfer.

References:

  1. Eichenwald, K. “Killer Pharmacy: Inside a Medical Mass Murder Case.” Newsweek. April 16, 2015.
  2. Fischman, J. “Have 25-million-year-old bacteria returned to life?” Science, v.268, May, 19, 1995, pp 1060-1064.
  3. Brandes, R. Aseptic Processing: Qualification of Personnel, Mass & Peither AG-GMP Publishing, April 12, 2012.
  4. Hayes, B. “Managing Aseptic Gowning with in Classified Environments.” Cleanroom Technology. April 8, 2015. Accessed on Apr. 5, 2017: http://www.cleanroomtechnology.com/technical/article_page/Managing_aseptic_gowning_within_classified_environments/107339
  5. Aseptic technique (n.d.). Mosby’s Medical Dictionary, 8th Edition. Elsevier Health Sciences, 2008. Accessed on May 10, 2017 from http://medical-dictionary.thefreedictionary.com/aseptic+technique
  6. European Commission EudraLex. The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1- Manufacture of Sterile Medicinal Products, November 25, 2008.
  7. Madigan, M. et al., Brock Biology of Microorganisms, Tenth Edition. Pearson Education, Inc. New Jersey, 2003.
  8. Abraham, Z. “Understanding, Preventing, and Remediating Mold in Cleanrooms.” IVT. December 17, 2013.

A guide to choosing cleanroom flooring

/در , /توسط

 

David Priest from Kemtile gives a rundown of the key considerations in cleanroom flooring.

when selecting a resin floor for cleanrooms and controlled environments

How often do you think about the floor in your cleanroom and controlled environment?

Chances are it’s quite often and changes in legislation – and maybe a change of production usage or methods.

A new floor may be required to resist chemical or solvent spills or other risks of contamination.

Or a change of usage could mean the floor has to be ESD to control static discharge.

Flooring experts can help with the specification process and will typically ask lots of questions before making any recommendations and developing the design.

Caustic solutions for CIP and solvents can seriously damage standard resin floors

Key considerations that should always be pointed out in the early stages of all potential projects.

include operational and maintenance requirements, installation and aesthetics – all of which are necessary to meet the stringent measures used to control particles to ultra-clean ISO standards.

Here are some of the most common questions and decisions that we ask to assess these and all of our healthcare and pharmaceutical clients during our initial meetings.

Meeting rigorous cleaning demands

To remove any spores in the air and to kill airborne germs, pharmaceutical sites tend to fumigate to control the microbial contamination in specialist areas.

This essential cleaning can be aggressive on certain floor finishes and vinyl. Certain epoxy and polyurethane systems are always recommended for these types of projects as they’re more durable and better able to withstand the very rigorous demands of such processing facilities.

Chemical resistance

In many areas, chances are that the floor doesn’t necessarily need to be chemically resistant, but there will be areas where it is extremely important.

Caustic solutions for CIP and solvents can seriously damage standard resin floors.

which is why it’s important to state what products are spilt – as well as their concentrations and temperatures – so that the correct level of protection can be specified. A lot of our systems can be enhanced with fiberglass reinforcement, which provides extra impact protection if required. Fiberglass reinforced “positive” side waterproofing membranes are another option to protect very important structural concrete floors or mezzanines, for example, from water ingress costs and associated costs.

A good supplier can manage a flooring project within the demands of a busy production environment

Every flooring solution in cleanrooms and controlled environments should also be Current Good Manufacturing Practice (cGMP).

compliant and installed using low Volatile Organic Compounds (VOC).

Current Good Manufacturing Practice is all about making sure that a facility is fit for purpose and will not pose a risk to the operation or the product. This is, of course, absolutely essential.

Seamless

Whether the floor can be seamless depends. If the structural floor slab has been designed to have some movement and has expansion joints, the answer is no. However, by using a “crack bridging” systems and full floor waterproofing layers with the appropriate final floor finishes, we’re able to achieve a truly seamless floor.

Eliminating joints means there is less risk of the floor breaking down due to traffic and, very importantly, it reduces the opportunity for bacterial growth.

Making sure that there are only smooth surface transitions – as well as having mechanical protection of the floor and cove – is critical to protect against the more serious problem of bacterial infection in any of the transition points.

Is ESD flooring needed?

Some flooring solutions in pharma facilities need to be ESD rated – for instance, if solvents are being handled or there maybe nuisance dust to consider. Even the use of FLT’s can generate very high levels of static that has to be controlled.

Within our range, we have numerous ESD flooring solutions to help control static.

They can be decorative and even have enhanced chemical resistance.

Slip-resistance?

You don’t want anyone to slip in your cleanroom, so make sure you specify textured, non-slip-resistant flooring solution.

It can be manufactured and installed in a variety of finishes and textures to help reduce slipperiness and increase traction. It goes without saying that it’s extremely important when it comes to protecting employees, customers and visitors.

The look, cleanroom flooring

You don’t have to be restricted on choice of colours and decorative blends and finishes in a sterile environment. Select a manufacturer that can offer a wide enough selection to meet every aesthetic demand and, very importantly, all performance prerequisites.

Complementary drainage solutions?

We always recommend complementing sterile flooring systems with pharma-grade stainless-steel gullies and drainage solution from reputable, experienced manufacturers. Ideally, partner with a supplier that offers bespoke-manufactured products that are able to withstand the harsh cleaning regimes that such sterile environments demand.

Pharma-grade gullies should offer fully sealed tops that can be opened after specific spillages – that perhaps can’t go straight to drain – so that they can be cleared away or neutralised.

cleanroom flooring

Kerbs and walls , cleanroom flooring

For the ultimate sterile and hygienic solution, we always recommend complementing seamless, non-porous flooring with prefabricated highly durable and water-resistant kerb and wall systems. There’s been plenty of innovation in this space and a good flooring specialist will be able to supply the latest kerbs and wall systems to deliver maximum protection from water and germ infiltration.

Investment in this area will mean there are no cavities behind the skirting boards or kerbs, which means there’s no place for germs and bacteria to develop. Joints are finished with an advanced germ-free sanitary sealant and installation is quick and easy.

We also recommend to customers that walls are treated with a totally seamless and non-porous fibreglass reinforced resin system, which again are available in a wide range of colours, sheens and finishes. This is a hard-wearing coating that’s able to withstand the rigours of high-pressure cleaning. It’s also chemical and impact resistant, making it ideal for ultra-sterile environments.

Certification and quality

Another thing to look for is to a contractor who complies with all the necessary health and safety standards.

A good supplier also needs to be experienced in managing a flooring project within the demands of a busy production environment.

They should be able to minimise downtime by working weekends, nights and during shutdowns. And by using the latest fast-curing, taint-free flooring solutions, it should be possible to return to normal working conditions quickly and cost-effectively, with minimal disruption. So let’s take a look at some scenarios…

Case Study #1 – Alltrista Plastics

Alltrista Plastics is a US-based specialist manufacturer of high-end technical plastic moulding solutions for medical, pharma, nutraceutical and specialty packaging. The company operates ISO Class 8 certified cleanroom moulding and assembly facilities in its heavy-duty warehousing environment.

To increase its packaging production capabilities, Kemtile’s brief involved the refurbishment of an existing warehouse facility into high grade cleanrooms.

the flooring in which was an asphalt finish over a concrete slab. Over a two-month period, racking was stripped out of the warehouse before the asphalt was then planed down to the base slab.

Kemtile’s flooring team then installed a total of 2000 sqm high-performance epoxy flooring systems.

throughout the new pharma production facility and cleanroom.

A further 1200 sqm was laid in the new warehouse with a four-component power troweled mortar applied to withstand rigorous demands of forklift traffic.

In the cleanrooms an epoxy quartz mortar was applied. This durable flooring system has a decorative slip-resistant surface.

Ideal for trowel application over rough substrates, this base also provides superior impact resistance. Meeting the aesthetic requirements of the client brief, a quartz-coloured top layer of was applied to produce an attractive floor surface that is also lightly textured for safety.

Case Study #2 – Volac

Volac is an international dairy nutrition business. This flooring design and installation project, at the company’s Felinfach plant in Ceredigion.

West Wales, saw Kemtile reunite with Whitland Engineering to build a new dryer tower that will increase capacity at this modern dairy production facility.

Using the latest membrane filtration and drying technologies, the plant produces Volac’s high-performance whey protein isolates for the sports and active nutrition markets.

lactose for use in a range of food applications and base powders for young animal milk formulas. cleanroom flooring.

The site is also powered by a low-emission biomass CHP energy centre, helping to deliver a minimal carbon footprint.

For this particular project, Kemtile specified 1576 sqm Stonhard Stonclad GS over four floors.

This high-performance epoxy system cures to an extremely hard, impact-resistant mortar and offers the benefits of abrasion, wear and chemical resistance.

The Stonclad GS epoxy resin was then finished with Stonkote HT4.

Its addition further improves cleanability and aesthetics as it hardens to an attractive gloss finish and increases resistance to damage.

These specifications were complemented with 834 sqm of Kagetec GFK – a hygienic tiled floor system.

with the benefits of quick installation and high mechanical, load-bearing properties, resistant to thermal shock.

Kemtile’s co-polymer screed provided the base for the project and a stainless-steel gulley system and drainage channels.

manufactured by from Wiedemann-Technik, were also installed. cleanroom flooring.

Kemtile is now a division of Stonhard, the global specialists in pharmaceutical and healthcare flooring that manufacture, design and install. “We’re working with an increasing number of leading international brands in the UK. We’re proud to call the likes of AstraZeneca, Reckitt Benckiser, GSK. Accord Healthcare, Alltrista Plastics and Thermo Fisher Scientific our customers.”

اتاق تمیز آزمایشگاه میکروبی

Importance of Cleanroom in Laboratories

/در , /توسط

A Clean Room, or cleanroom, is a laboratory environment that ensures that airborne particles are maintained at a very low concentration. This room is isolated, actively cleansed, and prevented from contamination from a range of particles and biological material including dust, airborne organisms, or vaporized particles. These rooms are necessary to protect human health and industrial product assembly, and their primary aim is to prevent the release of whatever particle is being handled inside it. They are highly specific environments as several parameters are controlled.

By Hidaya Aliouche, B.Sc.Reviewed by Sophia Coveney

The international organization for standardization (ISO) is a worldwide federation comprised of several national standard bodies that were created to set standards for similar technologies in different countries. In the context of cleanrooms, standards and grading have been developed to assess the air quality and cleanliness.

اتاق تمیز آزمایشگاه میکروبی

International standards for monitoring airborne particles in cleanrooms

In Federal Standard 209 (A to D) of the USA, the number of particles ≥0.5mm is measured in one cubic foot of air, and this count is used to classify the cleanroom. The Federal Standard 209Ewas the preliminary standard for the classification of clean zones and cleanrooms; however, a new global standard replaced this in 1999 (ISO 14644-1).

Satisfactory cleanroom air quality is essential to ensure the quality of the product being produced or the effectiveness of the process being performed in the cleanroom. To determine whether the cleanroom complies with the global standard, some form of airborne sampling is necessary.

The important thing

It is important to note that there is frequent variability in readings of airborne particles in cleanrooms due to the contributions of dynamic particulate levels, variability in sampling technique, and differences or inconsistencies between the calibration and maintenance of instruments. However, ISO classification offers a complete platform to control for the discrepancy between different instruments.

An ISO 14644-1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. ISO 14644-1 cleanrooms are classified from ISO 1 to ISO 9. Each cleanroom is classified according to the maximum concentration of particles per cubic meter or cubic foot. ISO 8 is the second lowest cleanroom classification and is considered to be the least clean cleanroom classification.

When Is a Cleanroom Required?

A cleanroom can be used for several applications across several industries. They are necessary for applications for which sterile and clean environments are necessary. With regards to the life sciences setting in which production is occurring,  the safety and quality of products is the primary objective. If too many particles enter the cleanroom raw materials, manufacturing processes, and finished products can be adversely affected.

An ISO 1 cleanroom classification is rare and is only implemented in cases of the most sensitive research and development processes is, for instance, those involving the construction of semiconductors or bioscience. An ISO 5 cleanroom is considered to be a high-grade cleanroom and is necessary for pharmaceutical applications. This may include the sterile filling of pharmaceutical drugs into their respective packaging. An ISO 7 facility is necessary for sub-sterile applications.

the primary objective

An ISO class 8 cleanroom is the lowest acceptable level for sterility. It is used when sterility is not considered to be the primary objective, but it is necessary to ensure a basic level of hygiene. Examples of such applications include the storage of pharmaceuticals.

It is important to note that these examples are indicative of these standard applications in practice. The standards are often set by a combination of several factors, which depend on the application of the cleanroom. Some applications may therefore fall somewhere between the levels indicated in the standards.

اتاق تمیز آزمایشگاه میکروبی

Cleanrooms ensure:

  • Maintenance of effective contamination control measures and their assessments
  • Identification of specific threats to product purity.
  • Informing on the performance of heating, ventilation, and air conditioning systems, cleanliness of personnel, gowning practices, equipment, and cleaning operations
  • Protection of the end-user (patients and healthcare providers) by protecting against biological contamination.
  • Protection of the workforce:  some raw materials in product manufacture can produce contaminants that could be hazardous to operators. Cleanrooms ensure the immediate safety of the environment for Personnel in the cleanroom through the use of drowning areas, protective equipment, and air filtration systems.
  • Secure product or process certification:  successfully and globally marketed products ranging from medical devices to pharmaceuticals require the manufacture to occur in a cleanroom that meets all parameters of international standards where the device is to be sold. By implementing these international standards, manufacturers can market to a larger customer base and therefore increase their product profitability.

اصول ساخت و احداث آزمایشگاه میکروبی

Requirements For Setting Up a Cleanroom

It is the responsibility of the manufacturers and research labs to meet minimum requirements and standards that apply in their geographical region.

Manufacturers and research laboratories must remain vigilant to changes to the international standards and be able to respond to them appropriately. There are a comprehensive set of requirements and regulations that have been described in documentation.  The most common/ ubiquitous of these include:

  • Cleanroom air monitoring system: as air quality is a critical determinant of cleanliness and air quality, enabling particle thresholds and therefore regulations to be adhered to.
  • Continuous testing for contaminant particles:  the average person in a cleanroom can add 100,000 0.3 microparticles per minute while in a standing position. Mitigating the risk generated as a result of particle production begins with testing such particles to determine strategies to prevent the build-up of excess particulates. The choice of filtration systems is dependent on the type of work, the personnel, and the quantities of particles generated in the cleanroom workspace.
  • Written procedures: To prevent harm to the users of any products generated in a cleanroom, contamination prevention measures need to be documented and submitted to the appropriate regulatory agency. Regulators require documentation as proof of preventative contamination strategies applied to both the product itself and the process used to generate it.

new challenges

The development of more complex products, including device miniaturization under nanotechnologies will increasingly present new challenges for cleanroom manufacturers. It is believed that automation will be used to leverage manufacturing, with the early implementation of automation in the assembly process enabling a low-cost means of ensuring cleanliness. It is also believed that artificial intelligence and machine learning can increase quality standards and reliability.

References

pass boxes

10 things to know about cleanroom pass boxes

/در , /توسط

Cleanroom products and pass boxes manufacturer Kleanlabs outlines the top 10 elements to factor when choosing the right pass-through box for a facility

Pass boxes are the perfect tool for transporting items in and out of cleanrooms. These boxes are widely used in laboratories, hospitals, pharmaceutical and light-industrial environments. They not only offer full protection but also facilitate transportation of products.

Cleanroom pass boxes come with different features and sizes, hence installing the right product is paramount. Here are some things to know when choosing the right cleanroom pass box for your facility.

1. Static, semi active and active pass boxes

Pass boxes are available in 3 different types: static, semi active and active. The main difference is the ventilation and contamination filtering.

A semi active box is recommended when building a new cleanroom because it offers flexibility. It can be used between cleanrooms and non-validated environments thanks to a HEPA-filter that removes 99.97% of contamination; plus it can also help the cleanroom achieve a higher cleanroom certification.

For an established cleanroom, an active box is often the better option because it already has all the equipment integrated required for complex air handling.

Finally, the static version is ideal when ventilation is not required in the pass box, for example, between two cleanrooms. It’s mainly used for non-sensitive, fast moving products.

2. Easy to clean

Choosing a pass box with flat surfaces is much easier to clean because there is only a flat surface to be wiped, saving time and making it easier to maintain. The material of the cover should also be considered since it should not react with any of the chemicals present in the cleaning products.

3. Easy to integrate

System independent cleanroom pass boxes fit into any wall systems. KleanLab’s range of cleanroom pass boxes work with any structure, including sandwich panels and gypsum boards.

4. Advanced air tightness

Precise closing is critical when transferring material into the cleanroom. An aluminum profile system can guarantee the perfect air tightness for cleanrooms. KleanLabs pass boxes are equipped with premium EPDM gaskets.

5. Interlocking

Interlocking is pivotal safety feature of a cleanroom pass box. The system makes sure that only one door is open at a time by using a pin. A led indicator light signals when the door at the other end can be opened. There is also an option for electronic interlock pins for a sluice system with an emergency button for even better safety.

6. Heavy duty body

When making a serious investment, durability is of key importance. Pass boxes with 50 mm thick, aluminium panels are resistant to bending and ensure long-lasting performance. Finding a material that can withstand the challenges of an industrial environment can be tricky. However AISI 304L stainless steel is completely shockproof and is very un-reactive to other chemicals.

7. Industry leading design

Anodized aluminium doors are both durable and easy-to-maintain. KleanLabs have created a unique design for their pass boxes which makes cleaning and using them very convenient. They are lightweight and sit flush to the cleanroom walls so that the accumulation of dust is avoided completely. This makes the pass boxes both functional and aesthetically pleasing.

8. Air pressure drain

Request an air pressure drain to prevent overpressure and constant inflating. This tool will help keep the air pressure under control and maximise safety.

9. UV light

Germicidal and antibacterial UV light can be installed into pass boxes for enhanced protection. The short-wave ultraviolet radiation destroys DNA pathogens.

10. Delivery and support

Once a decision has been made about the type of cleanroom pass box required, its time to choose a supplier. Whether its a small or big company, take a look at the services provided. Make sure that all the necessary accessories and parts can be ordered and delivered should there be a problem in the future. This will prevent having to replace the box or the whole pass-through at a significantly higher cost. Also check the estimated turn around times, from order to delivery. When a problem arises in a cleanroom, every minute is critical.