Using ESD Smocks in Your ESD Protected Area

Purpose of ESD smocks

The main reason people wear ESD smocks is to shield their insulative clothing and minimize the electric fields generated from their clothing. As we learned previously, all process essential insulators should be kept at a minimum distance of 12 inches from ESD susceptible items. Clothing fabric, particularly when made from synthetic fibres, is a significant charge generator. Non-ESD clothing fabric is an isolated charged insulator which cannot be grounded and the resulting charges can threaten ESD control.

An insulator (like clothing) will not let charges flow and holds the charge until either neutralized naturally over time (hours or days) or with an air ionizer (artificially under a few seconds). Until the charges are neutralized, your clothing may have several thousand volts that could suddenly discharge and damage nearby static-sensitive items.

The ESD Standard does not require ESD smocks, however they are a very practical solution for minimizing ESD events from a person’s clothing. ESD smocks can be an important step to demonstrating commitment to an ESD control program.

Cleanroom Wipers

Tly, the first name in cleanroom wipers.

Tly offers a variety of cleanroom wipes: dry wipes, pre-wetted or pre-saturated wipes, non-sterile and sterile wipes, industrial and laboratory wipes to meet the strict requirements of the pharmaceutical, bio-medical, and medical device, semiconductor & microelectronics, healthcare (USP and USP), aerospace, aviation & defense, laboratory, nutraceuticals/food, print, and automotive industries. Tly’s cleanroom wiper families include polyester sealed-border and sealed-edge wipers for the most critical environments and various cut-edge wipes for less critical areas.

Tly’s wipers are tested for fibers, particles, ions, residue, and endotoxin to ensure exceptional cleanliness for consistent quality and high performance.

In addition to our impressive selection of cleanroom wipers, we also carry cleanroom swabs, cleanroom sticky mops, and cleanroom garments.

What happens after a cleanroom renovation?

What should you be considering when planning cleanroom cleaning after a renovation?

There are many reasons why a cleanroom may require renovation, from replacing floors to ventilation and filtration systems, either way, the cleanroom will need some attention in order to make it fit for operation again.

Due to the disruption to the cleanroom and the inevitable addition of particulate and microbiological contamination, cleaning is a critical aspect of this process.

In a way, the cleaning processes following a renovation will be very similar to that of a new cleanroom build. In both scenarios, there are certain considerations when planning cleanroom cleaning which include:

 

What is the measure of success?

You first need to decide how ‘clean’ the cleanroom needs to be in order to be fit for operation. Whilst many people will worry about not doing enough cleaning, it can be just as easy to do more than is required. Rather than simply doing ‘what has always been done’ or ‘how it was done at a previous organisation’, time should be taken to assess what needs doing and the level of cleanliness that is required.

How will the required level of cleanliness be achieved?

Identifying what needs to be cleaned is the best place to start. You will need to consider floors, walls and ceilings, as well as inside and outside equipment, and any high-level cleaning or other specialist cleaning that may be required.

The next step in the process should be to understand what contamination is likely to be present after the renovation. There is likely to be significant physical contamination (e.g. dust and sealants), but you should also consider microbiological contamination such as spores.

Once you have clarity on what needs to be cleaned, you are ready to consider how the cleaning will take place. For example, does the cleaning need to be phased? Dependent on the cleanroom and its renovation, it may be best practice to phase the cleaning process into the following processes:

  1. Cleaning of gross contamination prior to HVAC system being turned on
  2. Cleaning before equipment is positioned and installed in the cleanroom
  3. Fine cleaning once HVAC system is in operation

The method of cleaning is vital in the process in order to ensure compliance when commencing work in the newly renovated cleanroom. You will need to ensure the cleaning methods are GMP compliant and follow best practice recommendations. It is also worth checking if the chosen cleaning processes have been validated or proven to be effective in any way.

The selection of materials and equipment should always refer to the point made earlier in the article about identifying what you are aiming to achieve from the clean. Asking yourself again if the clean needs to follow full GMP best practice methods and then deciding what will be required from there.

How will the cleaning be completed?

Personnel and resource are two key areas to consider when thinking about how cleaning will be completed after a cleanroom renovation. It is important to ensure the team who will be carrying out the cleaning are suitably trained and experienced, to ensure good practice is adhered to. Whether you clean using your own staff or have a professional cleanroom cleaning partner, the operators should be trained and familiar with all aspects of cleanroom gowning, material transfer, GDP and GMP. This includes GMP cleaning as well as the equipment and materials that they will be using throughout the process.

 

Once the cleanroom is clean, how will cleanliness be maintained?

Now that the deep clean is completed and you have a newly renovated cleanroom, you have a responsibility to maintain the cleanliness. Many organisations use specialist cleanroom cleaning companies to support the design and fulfilment of effective and efficient cleaning, starting with a deep clean and then leading into routine cleans.

The benefits of using a professional cleanroom cleaning service is their expertise built through specialisation, thorough training and experience. The quality of the clean is always consistent, with full documentation and traceability to support this. A cleanroom cleaning specialist will also take responsibility for cleaning equipment and consumables stock through their established supply chains and can be flexible around clients’ deadlines and time constraints.

Next time you are building a cleanroom or having a renovation done, it will serve you well to start at the beginning and plan cleaning as a critical aspect of the overall programme. Alternatively, you can outsource this service and rely on the work of professionals.

 

 

What is ISO 8 cleanroom classification?

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.

 

What is ISO 8 cleanroom classification?

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.

 

MRC Cleanrooms and Biologics Modular form new alliance

The two cleanroom experts have worked together to deliver a cutting-edge cleanroom wall system technology to the US market

MRC Cleanrooms and Biologics Modular form new alliance

MRC Cleanrooms and Biologics Modular have formed an alliance to deliver cutting-edge cleanroom wall system technology to the US market.

These modular wall systems will expand the current product matrix for Biologics Modular and offer a strategic position in the US market for MRC. With multiple manufacturing facilities worldwide, MRC can traverse supply issues and streamline manufacturing through a diverse supply chain.

These advanced manufacturing processes will shorten production timelines and deliver unrivalled construction timelines for US-based clients.

These modular wall systems will expand the current product matrix for Biologics Modular and offer a strategic position in the US market for MRC

The Biologics construction team will provide expanded services to the manufacturing marketplace, and MRCs’ wall systems will deliver shortened construction timelines and unparalleled quality to the US marketplace.

President & CEO Clark Byrum expressed his enthusiasm for the partnership, saying: “These innovative products from MRC will expand our facility construction delivery and provide expansion of services and products for our cleanroom clientele. MRC’s capabilities to manufacture and deliver these products give Biologics Modular another opportunity to help our clients expand.”

It is always exciting to introduce our cleanroom system into new geographical markets

These cleanroom panelling systems provide solutions for the pharmaceutical, healthcare, aerospace, renewable energy, microelectronic and high-end technology industries. MRC Cleanrooms and Biologics Modular will jointly provide the full design, delivery, validation, and installation of these systems for their respective US-based clients.

Global Sales Manager Samuel Hussain said: “It is always exciting to introduce our cleanroom system into new geographical markets. Our strategies aim at doing it in such a way that ensures end users don’t just benefit from access to our innovative cleanroom panelling systems, but also enjoy efficient and seamless project implementation, as well as structured and consistent after sales support and maintenance.”

“MRCs strategic partnership with Biologics Modular helps us to achieve that and more. Their expertise in the cleanroom segment, their project management competence, and now their use of the MRC cleanroom system, creates a partnership that will add a lot of value to the US market,” Hussain added.

Cleanroom cleaning: what happens after a cleanroom renovation?

What should you be considering when planning cleanroom cleaning after a renovation? Micronclean’s Business Development Manager David Giles explains

 

Cleanroom cleaning: what happens after a cleanroom renovation?

 

There are many reasons why a cleanroom may require renovation, from replacing floors to ventilation and filtration systems, either way, the cleanroom will need some attention in order to make it fit for operation again.

Due to the disruption to the cleanroom and the inevitable addition of particulate and microbiological contamination, cleaning is a critical aspect of this process.

In a way, the cleaning processes following a renovation will be very similar to that of a new cleanroom build. In both scenarios, there are certain considerations when planning cleanroom cleaning which include:

What is the measure of success?

You first need to decide how ‘clean’ the cleanroom needs to be in order to be fit for operation. Whilst many people will worry about not doing enough cleaning, it can be just as easy to do more than is required. Rather than simply doing ‘what has always been done’ or ‘how it was done at a previous organisation’, time should be taken to assess what needs doing and the level of cleanliness that is required.

Some of the reagents you will need could include Neutral Detergent, WFI, IPA/denatured ethanol, biocide/sporicide

Once an assessment of the required cleanliness has been completed, you need to consider how you will be defining ‘clean’. Depending on the cleanroom classification you are operating in, this might include limits for visible contamination, particulate contamination and microbiological contamination. In addition to clarifying how ‘clean’ will be defined, consideration should be given to how the cleanliness will be measured. There are a number of questions to ask yourself, for example, is physical and/or microbiological environmental monitoring required? If this is the case, do you have an adequate routine in place? You may also consider if a thorough survey is required.

How will the required level of cleanliness be achieved?

Cleanroom cleaning: what happens after a cleanroom renovation?

Identifying what needs to be cleaned is the best place to start. You will need to consider floors, walls and ceilings, as well as inside and outside equipment, and any high-level cleaning or other specialist cleaning that may be required.

The next step in the process should be to understand what contamination is likely to be present after the renovation. There is likely to be significant physical contamination (e.g. dust and sealants), but you should also consider microbiological contamination such as spores.

Once you have clarity on what needs to be cleaned, you are ready to consider how the cleaning will take place. For example, does the cleaning need to be phased? Dependent on the cleanroom and its renovation, it may be best practice to phase the cleaning process into the following processes:

  1. Cleaning of gross contamination prior to HVAC system being turned on
  2. Cleaning before equipment is positioned and installed in the cleanroom
  3. Fine cleaning once HVAC system is in operation

The method of cleaning is vital in the process in order to ensure compliance when commencing work in the newly renovated cleanroom. You will need to ensure the cleaning methods are GMP compliant and follow best practice recommendations. It is also worth checking if the chosen cleaning processes have been validated or proven to be effective in any way.

The selection of materials and equipment should always refer to the point made earlier in the article about identifying what you are aiming to achieve from the clean. Asking yourself again if the clean needs to follow full GMP best practice methods and then deciding what will be required from there.

Like any project, timelines can slip with little to no notice

Some of the reagents you will need could include Neutral Detergent, WFI, IPA/denatured ethanol, biocide/sporicide, but even once you have made the selection, there are some questions to ask yourself. Have the products been validated for use? Are the reagents compatible with one another and are they compliant? Once you have determined if the products are validated, compatible and compliant, you should ensure stable supply for the required quantity and period. This will require you to know how much stock you need for the cleaning and have an approved supplier for the items.

Reagents play a huge role in getting your cleanroom clean. However, you will also need to consider the equipment you use to clean, apply products and remove residues. Common equipment used for cleaning cleanrooms include vacuums, mops, wipes, sprays and fogging, to name a few. Additional equipment may be required for hard-to-reach areas of the cleanroom, including high level access equipment and safety equipment, etc.

How will the cleaning be completed?

Personnel and resource are two key areas to consider when thinking about how cleaning will be completed after a cleanroom renovation. It is important to ensure the team who will be carrying out the cleaning are suitably trained and experienced, to ensure good practice is adhered to. Whether you clean using your own staff or have a professional cleanroom cleaning partner, the operators should be trained and familiar with all aspects of cleanroom gowning, material transfer, GDP and GMP. This includes GMP cleaning as well as the equipment and materials that they will be using throughout the process.

You need to consider how you will be defining ‘clean’

By ensuring you have allocated sufficient time and resource for cleaning after a renovation, you increase your ability to complete the project on time and to the correct level of quality. Like any project, timelines can slip with little to no notice. With this in mind, it may be worth allowing a contingency within the plan or considering if the resource is flexible enough to meet a revised deadline.

Specific PPE and training may be required for all personnel. All safety considerations should be made before commencing the clean and planned into the project schedule.

Once the cleanroom is clean, how will cleanliness be maintained?

Now that the deep clean is completed and you have a newly renovated cleanroom, you have a responsibility to maintain the cleanliness. Many organisations use specialist cleanroom cleaning companies to support the design and fulfilment of effective and efficient cleaning, starting with a deep clean and then leading into routine cleans.

The benefits of using a professional cleanroom cleaning service is their expertise built through specialisation, thorough training and experience. The quality of the clean is always consistent, with full documentation and traceability to support this. A cleanroom cleaning specialist will also take responsibility for cleaning equipment and consumables stock through their established supply chains and can be flexible around clients’ deadlines and time constraints.

Next time you are building a cleanroom or having a renovation done, it will serve you well to start at the beginning and plan cleaning as a critical aspect of the overall programme. Alternatively, you can outsource this service and rely on the work of professionals.

History of Cleanroom

If the enterprise has deep clean industry, development and innovation of purification products, the depth of integration of upstream suppliers and downstream customers and production information, the formation of a strong supply chain integration capabilities, so, in the next ten years, the company will usher in the golden period of explosive development, a large number of Companies will be listed on the clean industry.

In our country, cleanroom technology began in the 60s of last century. At the time, cleanroom technology is a new technology to meet the needs of military products, precision instruments, aviation instruments and electronics industry, to meet the precision, miniaturization, high purity, high quality and high reliability of these industries. Nowadays, cleanroom technology has been widely applied in various industries, such as electronics, pharmaceuticals, medical and health, bioengineering, laboratories, food, cosmetics, instrumentation, aerospace and many other industries.

The cleanroom net is used to decipher the detailed industry chain of clean industry, and to rethink and rebuild the friends who just entered the industry and are committed to this industry.

Through decades of development, China cleanroom technology has gradually formed the industrial chain, including upstream purification equipment (such as FFU, clean sheet, transfer window, air shower room), clean room with all kinds of consumable products, more familiar purification supplies such as HEPA filter material (regarded as core clean technology), clean clothing, clean room and clean room use a variety of equipment, anti-static, dust products, supplies of the annual domestic market capacity more than 500~600 billion yuan, the scale is very large.

In addition, with the current air pollution, environmental destruction, the PM2.5 event has been copied to the application of clean technology in the industry raise a Babel of criticism of that field have been borrowed into people’s daily life, which is the most familiar to the air cleaner, more and more families have been using this product, the core technology products is the HEPA filter system. The domestic air purifier has a market share of 5 billion yuan, and the market share from Europe and America has a very large growth space.

The industrial chain of the middle reaches of the clean industry includes the related industries such as the design, construction, debugging, testing and operation of the clean room. In the middle reaches of the industrial chain, including related design institutes (such as electronic industry famous design institute has Chinese Electronic Engineering Design Institute, Ministry of electronic industry Eleventh Design Institute), the general contractor construction of clean room, clean operation room, professional certification (GMP certification pharmaceutical project) and debugging unit, and the entry of foreign capital management the company’s Chinese clean workshop (the famous beauty schiewer company, NE Pharma, etc.). In our country, the electronics industry spends in the clean room costs about 5 billion yuan, of which, with integrated circuit chip production line as the representative of the microelectronics industry each year about 3 billion yuan; the pharmaceutical industry, especially this year launched a new version of the GMP specification, forcing pharmaceutical enterprises new or re transformation of clean workshop to meet the new version of GMP request spends in a clean room facility system will cost more than 10 billion yuan, the peak is expected to reach 200~300 billion yuan; in the cleaning operation room of the hospital construction, the annual national new or renovated clean operation room will cost more than 9 billion yuan, and will maintain a growth rate of not less than 20%.

Cleanroom build of spray dry plant for small scale production

n designing the specific spray dry plant for small scale production (≤ 1 MT/yr) for VitaSquare Wolvega Netherlands, Kropman Contamination Control looked at many design considerations

 

Image 2Image 2

 

VitaSquare Wolvega produces nutritional premixes. In the Netherlands, the company enriches dry or ‘instant’ food with vitamins, amino acids, minerals, trace elements, and many more components.

For this to work, the nutrients need to be added in powdered form.

For the design of the specific spray dry plant for small scale production (≤ 1 MT/yr), many design considerations are implemented.

First of all process steps are identified and assessed for: product susceptibility, the risk of spilling, the method to clean in place as well as the exterior, including the room. Logistics of materials, product, staff and waste are also planned for.

Dosing and fine ingredients mixing

Logistics are set up to handle most raw material in bulk containers, positioned outside the process rooms, are hooked up to the process lines (Image 1). This all is done in a non-classified but controlled area of basic hygiene level.

 

Image 1Image 1

 

Spilling is not expected as all raw materials here are in containers or per piping such as feed water. Also, the CIP and waste flows are run as fixed piping. Specific additives are added in the processing room via a tank lid. (Image 2)

The tank itself is at the other side of the wall, with all its pumps, valves, sensors, actuators, wiring and supports. This leaves the processing room quite easy to clean. The various connections for the process and transfer steps can be made by transfer panels. The fine ingredients come to this processing room by an elevator from the ground floor. The elevator acts as an airlock as it is interlocked and flushed by overflow air maintaining the pressure flow cascade.

As shown in images on p55, the logistics are well separated as well as the majority of the process equipment is located in a non-classified hygienic zone. The area of exposure is very limited and in a controlled; ISO Class 9 environment.

Dycem Contamination Control chooses Israeli cleanroom mat distributor

UK-based Dycem has formed a strategic partnership with BioGate to distribute its cleanroom mats in the region

 

Image credit: DycemImage credit: Dycem

 

Dycem Contamination Control has chosen Israel-based BioGate to distribute its cleanroom mats in the region.

BioGate specialises in sales and marketing of life science, pharma and diagnostic products for the Israeli market.

In a LinkedIn post, BioGate announced that the two companies have formed a strategic partnership that marks a significant milestone in BioGate’s commitment to delivering top-notch cleanroom solutions to its clients.

The new mats on offer will remain sticky for 3-5 years without the need to peel of layers to prevent the spread of particles of 99.9%.

What is now on offer?

  • Exceptional Contamination Control: Dycem mats are engineered to effectively trap and retain contamination particles such as dust, dirt, and microorganisms. Their unique surface properties ensure maximum contact with shoes and wheels, minimising the transfer of contaminants into controlled environments.
  • With 3-5 years life cycle, 99.9% effective in inhibiting foot and wheel-borne contamination and captures 75% of airborne contaminants without the need of teer-off mats.
  • Durability and Longevity: Dycem mats are manufactured from high-quality materials that are resistant to wear, tear, and degradation. They are designed to withstand heavy foot and wheeled traffic, ensuring a longer lifespan and cost-effectiveness over time.
  • Easy Maintenance: Dycem mats are easy to clean and maintain. Regular cleaning procedures, such as vacuuming or mopping, can be used to remove trapped contaminants from the mat’s surface.
  • Customisable Options: Dycem mats offer a range of customisable options to suit specific cleanroom requirements. They are available in various sizes, colours, and adhesive or non-adhesive formats.
  • Environmental Sustainability: The mats are designed with eco-friendly principles in mind. Dycem uses recycled materials in its manufacturing processes and strives to minimise its environmental footprint.

Doors open for Cleanroom Technology Conference 2023!

The doors have opened for the largest Cleanroom Technology Conference to date! Co-located with Manufacturing Chemist LIVE, this event will welcome over 400 attendees for two days of talks and networking in Birmingham, UK

 

Doors open for Cleanroom Technology Conference 2023!

 

The doors have officially opened for this year’s Cleanroom Technology Conference at the NCC in Birmingham, and what a lovely sunny day for it!

Over the next two days, more than 400 attendees will walk through the National Conference Centre doors for two days of talks and networking with the best of the best in the cleanroom sector.

Companies such as Ecolab, AstraZeneca, Pfizer and many more, will be represented at the conference. So delegates will have the opportunity to converse with industry powerhouses.

 

Doors open for Cleanroom Technology Conference 2023!

 

The multi-sector, international event will cover a wide breadth of the industry through case studies and lectures from a panel of global experts, shedding light on the latest industry developments over the past year, as well as future projections for all sectors.

Topics covered include Annex 1, containment, sterility testing, regulations and standards, operation and validation, clothing & PPE, data integrity, HVAC and energy, cleanroom design & build, cleanroom operations, garments & consumables.