May 2023 - TLYCLEANROOM

What is ISO 8 cleanroom classification?

May 25, 2023/in News/by administrator

Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification

An ISO 14644-1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. Typically, these particles are dust, airborne microbes, aerosol particles, and chemical vapors. Beyond particle counts, cleanrooms often have controls for a number of other parameters like pressure, temperature, and humidity. Additionally, to be considered a cleanroom, the space needs High-Efficiency Particulate Air (HEPA) filters to remove particles from the air.

ISO 14644-1 Cleanrooms are classified from ISO 1 to ISO 9. Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification.

ISO 8 Cleanroom Standards

The allowed particle counts for an ISO 8 cleanroom depend on the referenced standard and its measurements. According to US Federal Standard 209E, ISO 8 cleanrooms are also known as Class 100,000 cleanrooms.

2017-08-10 ISO Cleanroom Standards

ISO 14644-1 replaced the federal standard and states that an ISO 8 cleanroom needs less than 3,520,000 of ≥ 0.5 micron sized particles per cubic meter of air. Only particles 0.5 microns or larger are measured in an ISO 8 cleanroom. This is done because the concentration of smaller particle sizes is too high.

ISO 8 Protective Requirements and Design Considerations

Designing a cleanroom requires taking additional regulatory standards and requirements into account based on industry and application. However, there are several general requirements and environmental parameters to consider for an ISO 8 cleanroom. For an ISO 8 Cleanroom, these include:

HEPA filtration
Air Changes per Hour (ACH)
Air pressure
Temperature and humidity
Amount of personnel working in the space
Static control
Lighting
Noise levels

Since an ISO 8 cleanroom is focused on measuring particles 0.5 microns or larger, the HEPA filtration system needs to be 99.97% efficient and a minimum of 20 air changes per hour is recommended. The final filtration of air occurs where the air enters the cleanroom. Additionally, it is most common for ISO 8 cleanrooms to employ non-unidirectional or mixed air flow patterns with low wall air returns. Common ISO 8 Applications

A wide variety of industries and applications have cleanrooms. Some of the most common with ISO 8 cleanrooms include:

Frequently Asked Questions on ISO 8

What is the difference between ISO 7 and ISO 8?

The two main differences between ISO 7 and ISO 8 cleanrooms are particle count and ACH requirements, which set them apart for differing applications. An ISO 7 cleanroom must have 352,000 particles ≥ 0.5 microns per cubic meter and 60 ACH per hour as opposed to ISO 8’s 3,520,000 particles and 20 ACH.

When is a cleanroom required?

A cleanroom can be used for a number of industries and applications. They are required for spaces where cleanliness and sterility are crucial. For context, an ISO 8 cleanroom is usually 5-10 times cleaner than a typical office environment. Specifically, in medical device and pharmaceutical manufacturing cleanrooms, the safety and quality of products is of the utmost importance, and raw materials, manufacturing processes, and finished product and can be affected if too many particles enter the space.

Setra’s CEMS for Cleanroom Environmental Monitoring

An environmental monitoring system is designed to gather, analyze, and notify on detailed cleanroom environmental data. For manufacturing spaces in particular, the goal of cleanroom monitoring is to assess the potential contamination risk of the product and remain in compliance with regulatory standards.

CEMS is Setra’s continuous environmental monitoring software that collects real-time data from in room cleanroom measurement sensors. Setra’s CEMS is a single system that can monitor a diverse facility with multiple locations, providing instant environmental data access and sophisticated analysis from a web-based interface accessible from any internet enables device. Real-time alarm notifications can be seen visually in software and sent to users via text message and email. Instant, up-to-date reports and graphs provide easy access to proper documentation for regulatory requirements. Setra’s CEMS helps to continuously monitor an environment during the manufacturing process to simplify operations, minimize the risk of contamination, and improve the quality of products.

Medical device manufacturing
Pharmaceutical manufacturing and compounding
Semiconductor manufacturing
Electronics manufacturing

CEMS accepts data inputs from a variety of measurement sensors, including:cems and hardware with wireless

Temperature
Relative humidity
Pressure
Velocity (ACH)
Particle count
CO2
Door opens and count

CEMS helps cleanrooms meet all the necessary regulatory requirements for ISO 14644, USP<797>, USP<800>, cGMP, EU Annex 1, GAMP, Joint Commission, FDA 21 CFR Part 11, EU Annex 11, and GAMP5. With simple networking and dependable remote access via the secure SetraCLOUD, users can save time and money with data exports and reporting features.

From the client’s perspective: designing an ISO Class 8 cleanroom

May 17, 2023/in News/by administrator

Univercells Technologies’ Head of Manufacturing & Supply Chain talks about his approach to building a scalable pharmaceutical manufacturing facility in Belgium. Gareth Crothers from Univercells explains

Belgium is currently positioning itself as a Biotech valley, with a mixture of established “Big Pharma” companies and cutting-edge startups. Given the ready access to highly educated and experienced biotech professionals (including engineering firms) within a relatively small area, it is fertile ground for establishing new biotech activities.

Within this context, Univercells Technologies was founded in May 2020 as a spin-off of the company Univercells. Its mission is to focus on the commercialisation of its novel biomanufacturing technologies product portfolio – the scale-X (trademarked) bioreactor range and the NevoLine (trademarked) Upstream platform. Located in Nivelles, the manufacturing activities for the scale-X (trademarked) bioreactor range and associated Single Use Technology (SUT) such as manifolds, require the use of a cleanroom environment in order to control particulate levels.

Considerations for cleanroom design, construction, and operation

The first consideration for building a cleanroom is which level you need to attain and maintain for your operations. There are well established international standards for this, including ISO 14644-11 (particle count limits only) and EU GMP grades (particle and microbiological). The standard that you target should always be based on the products that you manufacture, as well as your customers.

Final drug products destined for injection into patients require more stringent conditions in terms of both particles and microbiological levels than SUT that will be irradiated before use in upstream processes. Licensed drug products are subject to regulatory requirements whereas biotechnology equipment must meet customer expectations.

Choosing the cleanroom level is important as targeting a more stringent grade than strictly necessary “because it is better” will engender significant incremental cost increase in terms of room construction, qualification, energy consumption, cleaning, gowning, and routine environmental monitoring. On the other hand, targeting too low will engender significant re-engineering costs and potential business disruption if the classification does not meet product, regulatory, or customer needs.

At Univercells Technologies, our product range and customer expectations led us to target an ISO Class 8 classification.

Targeting a more stringent grade than strictly necessary ‘because it is better’ will engender significant incremental cost increase

The second consideration is the surface area you need for your operations. Here again, there is a balance to be found. A cleanroom that is under-dimensioned will restrict capacity and could cause operator discomfort; it could even become an EHS problem in terms of personnel/material flows or workstation human-factor design. Also, an over-dimensioned cleanroom will again engender significant incremental cost increase in terms of room construction, qualification, energy consumption, cleaning, and routine environmental monitoring. In a small but rapidly growing company, it is possible to have a modular approach where the basic personnel and material airlocks are in place, and additional cleanroom space can be added in extension as needed.

This is the approach that was adopted at Univercells Technologies: the cleanroom capacity initially installed in 2019 (before the spin-off) was doubled to 1830 sqm in 2022 as product volumes and product range complexity increased. The additional surface area was added in a cost-effective way by leveraging the original infrastructure, positioning Univercells Technologies for the next few years of growth (product range and volumes) without having to move to costly shift operations

It has also given the company a greater flexibility in the organisation of the cleanrooms, an important enabler for creating leaner manufacturing processes.

As a third consideration, the choice of engineering partner for the cleanroom design and construction is important. For smaller companies with a lower level of cleanroom needs, such as Univercells Technologies, a cost-effective approach can be to work with smaller local engineering companies as opposed to larger international groups.

The trade-off here is that larger international groups are more likely to have experience of working in a regulated pharmaceutical environment with the associated documentation requirements; where smaller local companies can sometimes struggle with providing the needed level of documentation in a timely manner without multiple iterations.

Finally, a company also needs to consider the operating parameters for the cleanroom at the targeted classification. These include gowning, cleaning practices, and HVAC optimisation. Each of these parameters require a balance to be struck: too little and the classification will not be maintained; more than necessary, and costs can rapidly rise.

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A good example of this is cleaning: monthly cleaning of all surfaces on an ISO-8 area with a sporicidal agent is arguably over-kill, especially since such an agent requires neutralisation if corrosion of metallic components is to be avoided. Setting this at the right level before initial qualification is important as reducing the cleaning, gowning, or HVAC regimes after this will certainly require requalification (with the associated costs).

There are several ways to sensibly target the parameters for a given classification; these include use of engineering guides (such as the ISPE) and benchmarking with companies having similar product lines. Nevertheless, periodic review of actual operating conditions as the business evolves is essential e.g. given the significant increase in energy costs throughout 2022, the business case for creating a reduced HVAC regime for non-manufacturing periods such as nights and weekends has become much stronger.

The Guide to Buying Cleanroom Swabs

May 6, 2023/in News/by administrator

If you have a cleanroom, you understand the importance of meeting stringent requirements. So does Puritan Medical Products. We manufacture our PurSwab line of critical environment (CE) swabs in our ISO 13485:2016-certified and CE-compliant facility to provide the reliable, consistent performance you expect from the end products that you purchase. The question is, what type of swab is best for your specific needs?

As you read through the overview of swab shafts and tips below, you’ll see our PurSwab brand line of swabs offers plenty of choices for cleanroom applications. With these details on our tipped applicators, you can confidently select the cleanroom swabs that best meet your needs.

What are cleanroom swabs?

A cleanroom’s controlled environment must minimize the pollutants such as dust and other airborne particles. However, even the cleanest environments feature materials, systems, and people that can potentially generate microscopic particles despite the best protections. Lessening this emission through careful choice of materials – including cleanroom swabs – is important.

Whether you’re manufacturing sensitive electronics, medical equipment, pharmaceuticals, or other delicate components, you have to be able to trust that your cleaning solutions meet your minimum for allowable particles per cubic meter. Cleanroom swabs are specially formulated to reduce the potential for lint and other residue, among other specialized features.

Understanding the types of cleanroom swabs

Just as there are many types of cleanroom applications, there are cleanroom swabs specially formulated to meet unique needs. These simple tools have two critical components to consider:

Shaft material: You have several options to choose from when it comes to swab handles, including wood, polypropylene, and paper. This variation allows users to select a material with the appropriate amount of stiffness or give for the task at hand.
Swab tip: There are far more options available when it comes to the tip of your cleanroom swabs. These range from cotton and compressed cotton to foam, foam over cotton combinations, knitted polyester and microfiber. The option you select will depend upon your need for absorption of cleaning agents or liquid contaminants, allowable abrasiveness and potential for linting, and other features. Some cleanroom swabs’ tips are formulated to offer additional benefits, including chemical resistance or antistatic and electrostatic discharge (ESD) properties.

Choosing the right cleanroom swab handle

Below is a deeper dive into the benefits and applications of each cleanroom swab handle material to help you match the appropriate tool to your application:

Polypropylene shafts

Molded or extruded options are available
Can be glass-filled for extra rigidity
Can be blended with carbon for conductivity
Can be blended with inherently static-dissipative polymers

Paper shafts

Compressed
Stiff
Biodegradable
Most often used with compressed cotton/lint-free tips
Used in manufacturing disk drives
The paper is stiff, clean, and makes for a “green” tip-to-toe construction

Wood shafts

Northern white birch
A “natural” material
Rigid
Contains particulates, so not typically recommended for cleanrooms

Choosing the right cleanroom swab tip material

Below, we’ve outlined the benefits and uses of each cleanroom swab tip material to help you match the right properties to your application. However, it is also important to note that many of these swab tips come in varying shapes – including pointed, rectangular, and corkscrew – to aid users in specific cleaning or application tasks.

Knitted Polyester

Soft, non-abrasive, and lint-free
Can easily withstand IPA, acetone, and other solvents
Non-absorbent
Low particle generation and low non-volatile residues (NVRs)
Made in a Class 1000 cleanroom
Ideal for cleaning electronic and communication devices and perfect for instrumentation and medical device manufacturing

Microfiber

Soft and non-abrasive
Low particle generation and low NVRs
Absorbent
Resistant to normal cleaning solvents, which makes them ideal for removing contaminants and excess materials in fine assembly environments
The fiber is made from denier thread smaller than polyester
Suitable for cleanrooms, fiber-optics, and component manufacturing

PurSwab foam

Synthetic – polyurethane foam
100 PPI provides good particle entrapment
Options include open-cell, closed-cell, dissipative, highly absorbent, and chemical-resistant styles
Non-linting, making it good for removing epoxy residue from connectors, in general cleaning, or as a flux remover
Thermal edge seals and thermal bonding to the handle helps ensure the sponge-like foam will clean up unwanted particles without releasing any into your environment

Foam Over Cotton

Made from shred-resistant urethane foam over USP pharmaceutical-grade cotton for the best absorption that performs well when cleaning with solvents

Friction bond
Foam over cotton holds up better under vigorous use than stand-alone cotton
Extra absorption

Chemical-resistant foam

Made of a unique polymer that stands up to most solvents and aggressive chemicals (including acetone)
Used for general cleaning, removing and applying adhesives and other solutions
The slight texture of the foam creates a light abrasion

Antistatic and ESD materials

To prevent electrostatic discharge (ESD) and static buildup electronics and other sensitive devices should only be cleaned with ESD and/or anti-static swabs
Designed for working in and around static-sensitive components and parts
Anti-static applicators are made with an anti-static foam tip and a conductive polypropylene handle or standard wood handle
ESD applicators are made with anti-static handles and have unique tips, some are made of ESD conductive foam, polyester, cotton, and non-woven materials

Cotton tips

“Standard”
Absorbent, linty
Soft
Many configurations possible
Inexpensive, readily available
Useful for non-medical applications

Cotton tips for lint-sensitive applications

Non-linting and residue-free
Soft
Some offered in anti-static packaging
Typically double-tipped
Used in HDD manufacturing
Suitable for cleanrooms
Smallest tips starting at 2 mm
Bulb and pointed styles