Frequently asked questions about cleanrooms

Some industries (such as pharma, biomed, chemical, cosmetics, food and hospital-healthcare) have stringent hygiene requirements that go far beyond routine cleaning.

With competitive price and timely delivery, EZONG sincerely hope to be your supplier and partner.

Since these are sensitive processing environments, the concentration of airborne particles in the room must remain within a well-defined limit: an environment that respects this characteristic is called a cleanroom or cleanroom.

Depending on the sector, there are international standards that strictly regulate cleanrooms. Thus, there are differences between a food cleanroom, a pharmaceutical cleanroom or a hospital cleanroom.

The standards provide rules on several aspects of clean rooms:

1. The concentration of particulate matter per cubic metre;
2. The filtering and cleaning capacity of the air;
3. The type of equipment, materials and work machines that can enter;
4. The means of transport suitable for entering clean rooms;
5. The clothing of personnel entering and leaving the clean rooms.

Read also this article to learn more: The importance of clean rooms today, in production environments where cleanliness must be total.

13 Cleanroom Questions Answered

If you are involved in the manufacturing, processing, testing, and release of sterile and non-sterile products, you need to understand the basic concepts of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation, and use of cleanrooms and the sterilization processes within your industry.






ComplianceOnline's seminar 'Cleanroom, Microbiology and Sterility Assurance Practices' provides insights about various key elements of sterility assurance and contamination control such as cleanroom regulations, classification, sources and types of particles, design requirements, validation/qualification, operations, environmental monitoring program requirements, excursion investigations, datatrending, microbiological processes/methodology, and cleanroom cleaning/disinfection.

The following section provides answers to some basic cleanroom questions.

What is a cleanroom?

The FDA defines a cleanroom as an isolated environment, that is strictly controlled with respect to

• Airborne particles of viable and non-viable nature
• Temperature
• Humidity
• Air pressure
• Air flow
• Air motion
• Lighting

How is the level of contamination in a cleanroom measured?

A cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at specified particle size.

What are the common cleanroom design flaws?

• Inefficient placement - a design that doesn't support your processes
• Maze-like walkways
• Poor ventilation
• Unable to maintain temperature -too hot, stuffy or freezing cold

What are the key cleanroom design considerations?

• Stakeholder consultations
• Specification of the correct grade
• Power requirements
• Clearance space between the ceiling and walls of your cleanroom and the ceiling and walls of your manufacturing facility for necessary services
• Cold tracking - the movement of temperate along a conductive material
• Interior isolation
• Personnel and workflow
• Static electricity and humidity control
• Capital cost vs running cost
• SOPs to ensure that the cleanroom is effectively operated to maintain air quality
• Authorities and regulatory compliance
• Future expansion

What are some gaps in cleanroom design that could pose a significant risk to the cleanroom's long-term compliance even if the design was not in conflict with the GMP standard or regulation?

• Cleanroom surface issues
• Rivets presented as a lump of silicon over the top or a hole directly into a stagnant, uncontrolled part of the facility
• Mushroom bolts
• Grey electrical conduit running down the wall
• Windows with a sloping sill
• Completely sealed cleanroom doors
• Bad silicon sealant application
• Insufficient light
• Too much light
• Things that poke into cleanroom environments
• Internally insulated ducting

What are the sources of cleanroom contamination?

• Personnel
• Equipment
• Tools - Everyday tools, such as regular household or industrial cleaning products (brooms, mops, dusters) and writing supplies (pen, pencils, paper).
• Raw materials/ Products
• Air in the facility
• The water used in the manufacturing process
• Static electric charge

What are cleanroom classifications?

Clean rooms are classified according to the cleanliness level of the air inside them. There are many classification types that govern cleanroom cleanliness, but the key system was laid out by the International Standards Organization. ISO classifications apply to all cleanroom industries and applications. This standard includes the cleanroom classes in this standard include: ISO 1, ISO 2, ISO 3, ISO 4, iso 5, ISO 6, iso 7, iso 8 and iso 9. ISO 1 is the highest classification according to iso -1.

Standards are regulations like USP or ASTM International standards are organized by industry-specific requirements.

What factors determine the level of cleanroom you need?

Different factors determine a cleanroom that meets your needs:

• Government regulations
• Industry standards
• Customer requirements
• Ease of cleaning
• Restriction of access
• Particulates
• Temperature
• Humidity
• Microorganism

Where to find cleanroom guidelines?

• WHO GMP Guidelines (International)
  • WHO Technical Report Series, No. 902,
    • Annex 6: Good manufacturing practices for sterile pharmaceutical products
  • WHO Technical Report Series, No. 961,
    • Annex 5: WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
    • Annex 6: WHO good manufacturing practices for sterile pharmaceutical products
• EEC GMP Guidelines (EU, Partly international)
• US FDA cGMP Guidelines (USA, International)
• ISPE Guidelines (International)
• PDA Technical Report 13 (Revised): "Fundamentals of an Environmental Monitoring Program" (USA)

Where to find cleanroom regulations?

• DIN EN (EU, International)
• Volume 4 EU "Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products" (EU).
• PIC/S GMP Guide (Part I: Basic Requirements For Medicinal Products)
• PIC/S Guide To Good Manufacturing Practice For Medicinal Products - Annexes
• USP "Microbiological Control and Monitoring of Aseptic Processing Environments" (USA)
• 21 CFR (Parts 210, 211, 600-680) - cGMP regulations

What are the ISO Standards for Cleanrooms?

• ISO Standards (3 Parts):
  • ISO -1 "Biocontamination: Control General Principles"
  • ISO -2 "Biocontamination: Evaluation & Interpretation of Data"
  • ISO -3 "Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces"
• ISO Standards (8 Parts):
  • ISO -1 "Classification of Air Cleanliness"
  • ISO -2 "clean room Testing for Compliance"
  • ISO -3 "Methods for Evaluating &Measuring Clean rooms & Associated Controlled Environment"
  • ISO -4 "Clean room Design & Construction"
  • ISO -5 "Clean room Operations"
  • ISO -6 "Terms, Definitions & Units"
  • ISO -7 "Enhanced Clean Devices"
  • ISO -8 "Molecular Contamination"

How to maintain a cleanroom?

• Ensure that the amount of contamination that escapes from your manufacturing operations is at the minimal level
• Do not provide cleanroom access to anyone who is not trained - People are the largest sources of contamination
• Regularly clean the cleanroom according to strictly controlled procedures
• Regularly maintain all equipment
• Regularly monitor filters and airflows and ensure frequent recertification of the cleanroom

What are the best practices for handwashing in cleanroom?

Although the use of gloves in a cleanroom is a standard practice, those who wear gloves are less likely to wash or clean their hands before donning them. So, make sure of good hand hygiene to avoid the vulnerability of cleanroom to bacteria or potential introduction or transfer of microbes such as fungus and viruses.

What factors determine your cleanroom classification?

How to Decide What Cleanroom Classification You Need

*This post is part of a much larger pillar post.

If you clicked on this blog post, chances are you&#;re trying to decide which cleanroom classification is right for your business.

Or, maybe you&#;re not sure exactly what iso cleanroom classification is. 

Either way, you&#;re in luck. In this post, we&#;ll be talking about what ISO classification is, why it&#;s important, what factors should drive your decision making process, and explain how you can improve your cleanroom class at a later date.

The information in this blog will apply to all industries, including semiconductor manufacturing, pharmaceutical, or even automobile production. However, most of the examples we&#;ll reference in this post will be based on the pharmaceutical industry, so please keep that in mind.

Ready to learn more about cleanroom ISO classifications? Keep reading.

Why is ISO Classification Important?

If this is your first time diving into the world of cleanroom classification, the idea of ISO classes may be a bit confusing. So, before we get started, let&#;s go over some fundamentals.

In the simplest terms, ISO classifications are ranges of acceptable particulate. Based on what&#;s needed for your process, different classifications of cleanrooms will be necessary. The higher the number, the more particulates you&#;ll find in the room. So, ISO 5 cleanrooms will have less particulate and contamination than an ISO 8 cleanroom.

Now that we&#;ve got the basics down, let&#;s look at the factors that will impact what iso class of cleanroom your process will dictate.

1. Industry

The first and most important factor that will always dictate the class of cleanroom your business needs is the industry you operate in. You should consider that every industry has different requirements for particulates, finishes, and cleaning, and it&#;s up to you to gather this information.

What&#;s interesting is that although some industries have federally regulated standards, most do not. One big industry we see with FDA regulations is the pharmaceutical industry. Some of these regulations include USP, 797 & 800, and 503B. 

Before deciding on the classification of cleanroom you want to install, look at your competitors who have more experience in this realm. By doing this, you&#;ll save yourself time, money, and potentially hours of research. 

2. Competition

Like we mentioned previously, you can learn a lot from your competition. Not only will it help you stay legally compliant, it&#;ll also help you bring in new business. Now we&#;ve got your attention.

How can having a lower ISO cleanroom, or any cleanroom for that matter, help you compete? Let&#;s look at an example. 

Say you just bought a new business that creates decals for automobiles. You&#;ve been invited to bid for a project that could be a huge source of revenue for your company. Your two biggest competitors have an iso 8 cleanroom, and an iso 7 cleanroom. You don&#;t have a cleanroom, but your product turns out great..most of the time. 

The bid will more than likely go to the company with an ISO 7 cleanroom. This is because of one very important factor: higher predicted outcome of quality. A higher predicted outcome of quality means that you&#;re more trustworthy, cost-efficient, and easier to work with, regardless of what your sales rep says. 

Simply put, having a cleanroom with a class on par with your competitors helps you stay current and put your best foot forward when bidding for jobs.

3. Internal Quality Control

Last but certainly not least is internal quality control. A lot of people miss just how important this is. By doing the legwork up front to build a cleanroom for quality control, you&#;re saving your business a large amount of money each year by eliminating product waste.

Not only that, but you&#;re also setting a standard for yourself that your customers and competitors will notice. By establishing guidelines for product quality, customers will trust what you produce that much more.

How can I determine which class of cleanroom establishes a high level of quality control for my business? That&#;s where we come in. Vernick has worked on cleanrooms across a variety of industries, and have developed a specific process for helping you decide on an ISO classification that&#;s right for you.

First, we have a conversation about the type of issue that&#;s occurring in the process, and how much particulate is entering the room. Next, we&#;ll run an analysis of the room to see what and where the issue really is. Finally, we&#;ll make suggestions based on what we&#;ve seen, and make the adjustments necessary to your cleanroom process. 

Setting a level of quality control can be difficult due to self-policing, but it is absolutely crucial to the health of your business.

Closing

Don&#;t let cleanroom ISO classifications intimidate you. By using these three sections as a guide, you can be well on your way constructing the perfect cleanroom for your process. As always, our team of cleanroom experts are ready to assist you if you have any questions.

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Need help deciding what classification of cleanroom you need? Contact us.

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