Three Tests for Disinfectants for Cleanroom Validation

You need to control fungal contamination in your cleanroom, and you need to test the disinfectants for validation. Here are three to consider.

Controlling fungal contamination in your cleanroom requires cleaning and disinfection procedures. Your disinfectant application is a critical step that needs validation. Since many agents that are effective against vegetative fungi aren’t effective against fungal spores, it’s necessary to conduct a series of tests to demonstrate your agent’s efficacy. Here are three testing methods to consider.

  1. Suspension tests. These are especially valuable for finding how much time is needed to reduce organisms to an acceptable level. However, they don’t reveal any variations in efficacy that happen when disinfectants are applied to different surface types. The test procedure is to suspend the microorganism in an appropriate dilution of the test disinfectant. At designated time intervals, samples are removed for viable counts. The test is conducted at room temperature.
  1. Carrier tests. These are specific to hard-surface disinfection agents, and they’re performed under the conditions that match your facility’s specific application. Typical cleanroom surfaces are stainless steel, but can also include terrazzo flooring, vinyl, epoxy, and glass.
  1. Statistical comparisons. While both of the above tests are quite reliable in evaluation a disinfectant’s efficacy under lab conditions, they guarantee results in your actual cleanroom environment. To address this, you need to perform statistical comparisons of the frequency of isolation and the numbers of organisms isolated before and after a new disinfection program is implemented. Trend the environmental data over the course of a year to find seasonal variations that may cause facility or maintenance issues.

When it’s time for cleanroom validation, trust the experts at Gerbig Engineering Company. We’ve provided cleanroom validation, certification, and construction for thirty years. Contact us at 888-628-0056 or info@gerbig.com.

Methods for Testing Container Closure Integrity : Cleanroom Products – Part 2

Container closure integrity is a must for drug manufacturers. Here are the last 2 of 5 common methods to test this integrity

As mentioned in part 1, container closure integrity (CCI) is paramount for the entirety of the shelf life of any drug product. There are numerous ways to test CCI. In part 1, we discussed dye ingress testing, vacuum decay, and headspace analysis. Here we will wrap up with the final two most popular methods: helium leak and high voltage leak detection.

Helium Leak. While the previous methods discussed are not extremely sensitive, this test is the most accurate, giving the most reproducible results. Helium is one of the safest gases to use for such a test, and the vials or syringes can be filled manually or arrive with helium in them.  A mass spectrometer that only detects helium ions picks up the rate of helium leaking from a container. Vials can contain liquids or lyophilized product; syringes must be empty. The helium does destroy the product, but this test can pinpoint a leak, and it can be conducted in cold temperatures.

High Voltage Leak Detection (HVLD). This method is very practical for stability studies, biologics, and containment systems holding liquid with no headspace. A high-voltage current is applied to the liquid in the container, and a voltage differential identifies an integrity breech. It’s a non-destructive method that produces rapid results and requires little operator skill.

The right CCI test will depend on your specific application and needs. For cleanroom validation or certification, contact Gerbig Engineering Company. We have thirty years of experience in the cleanroom industry: 888-628-0056; info@gerbig.com.

Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1

There are a number of alternative methods to test container closer integrity for drug products. Start comparing these methods here.

Container closure integrity (CCI) of a drug product must be preserved throughout its entire shelf life. There are a number of ways to conduct a CCI test, each with its pros and cons.  Here is a rundown of the most familiar methods.

  1. Dye Ingress Testing. This is probably one of the most popular tests used. Some of the benefits are that being a visual test, the drug can be in its final configuration (syringe or vial.) It also only requires an observation of the dye to see whether the container has been compromised. This is a basic and efficient means of testing; however, it should only be used as a gross analysis of cracks and misalignment. There are much more sensitive tests available for a full analysis.
  1. Vacuum Decay. This test uses a rise in chamber pressure to expose leaks. While the previous test destroys the product, this test is non-destructive and can be used on solid products. Additionally, it can be performed in vials of any color, whereas the dye ingress test requires a clear container. On the other hand, the method is labor-intensive, requires specific instrumentation, and only offers a pass/fail result as opposed to isolating the source of the problem.
  1. Headspace Analysis. This is a highly-sensitive, non-destructive test. It uses frequency modulation spectroscopy to determine the pressure inside the vial. It’s a rapid test that can be conducted on varying container sized. It’s more accurate than the previous two tests. However, the containers do need to be transparent, the test can’t be done on syringes, and you cannot pinpoint the source of a leak

In part two, we will evaluate a couple of methods that are more sophisticated in their sensitivity. If you need assistance with compliance for your cleanroom, Gerbig Engineering Company can help. We offer cleanroom validation and certification. Our experts also build hardwall and softwall Airecell cleanrooms. For more information, call 888-628-0056 or email info@gerbig.com.

3 Ways to Sterilize Cleanroom Apparel

Sterility is a major part of every cleanroom, be it the equipment, the tools, the product, or the structure. In aseptic cleanrooms, the garments must also be sterile. Most companies require all components in an aseptic cleanroom – including garments – to be terminally sterilized to 10-6SAL.  There are three methods of achieving this: autoclaving, ethylene oxide (EtO), and ionizing radiation (gamma or electron beam.)

 

1. Steam Autoclaving

As the name suggests, sterility is attained in this method using steam and pressure. The garment is wrapped in a vapor-permeable bag and placed under a high temperature. The steam carries heat to every surface of the garment. So long as the object in the autoclave isn’t heat, pressure, or moisture-sensitive, this method is reasonably efficient and convenient. However, it typically shrinks garments up to two sizes. Aside from the obvious problem here, it degrades the material more quickly. Wrinkles also set in, making the garments unsightly.


2. EtO

This is a gas that kills microorganisms, and this sterilization method was used widely for years. It works by using a vacuum chamber to evacuate the air from wrapped objects and replace it with EtO. After sterilization, the gas is evacuated and air replaced. The greatest downside to this is EtO’s dangerous effects on humans. Items sterilized with this method had to be quarantined up to two weeks while the EtO dropped to a safe level. For this reason, extra garments need to be on hand to use while other garments are outgassing.


While both methods have their upsides, neither is considered the most advantageous given the culture and needs of today’s cleanroom. This brings us to the third, most preferred method of garment sterilization…

3. Ionizing Radiation

This includes two forms, though gamma irradiation is the only one being successfully used in cleanrooms. The electromagnetic radiation of gamma rays has great penetrating power, like an x-ray, but with a shorter wavelength. Sterilization with these rays occurs after the garments have been laundered and packaged. Before gamma irradiation, however, you must follow validation protocol to determine the dosage required to obtain the desired sterility. Since this kind of radiation is destructive, it’s important to use the lowest possible dose, which may be lower than the 25 kilograys we know are sufficient. This will help extend the garment’s life significantly.

Liability also plays a role in using the lowest possible dosage. Garment service providers undergo extremely rigorous customer audits because if the process drifts out of control or the dose has not been set properly, it can put a person’s life at risk. Therefore, the calculated sterilization dose for gamma irradiation will be included in the customer specifications for the product.

 

When it comes to cleanrooms, every aspect of sterilization and sanitation affects compliance and validation. Gerbig Cleanrooms knows how vital every detail is the overall process. If you need cleanroom validation or certification, or if you need cleanroom construction, reach out to us. We know what you need to achieve and maintain success: 888-628-0056; info@gerbig.com.

Why Small Particles Stick – Clean the Cleanroom

We all know that the smaller the particle, the harder it is to clean. They always get stuck in those tiny, hard-to-reach spaces. Here’s why.

Dispersion forces. They make a gecko’s feet stick to walls. They also make small particles get stuck in really tiny places and cause them to be so hard to clean. Let’s see why this kind of force is making your life cleaning the cleanroom so difficult.

Molecules that have dipoles, or permanently positively and negatively charged sides are associated with polar and hydrogen bonding forces. However, dispersion forces are a property of all molecules regardless of an inherent dipole. Since electrons are always in motion, momentary fluctuations can occur when more electrons are on one side of a molecule than the other. This causes a momentary negative charge on the side with more electrons and a positive charge on the opposite side, creating a momentary dipole.

When a molecule comes close to a molecule with a momentary dipole, its electrons are compelled to move. This creates an attractive force between the molecules. If the colliding molecules don’t have enough energy to bounce back, they stick together. The dipole then lasts as long as the molecules are bound together. The pair becomes a dipole in itself, creating a chain reaction.

Since the molecules have to be very close together in order to adhere, crevices become fertile grounds for dispersion forces. This is also true when soil dries. Soil molecules that are in liquid become close enough together during evaporation to attract the dispersion force. Thus, dried soil is tougher to clean than wet.

You see why it is so important to perform critical cleaning as soon as possible. The longer you wait, the harder the job will be. You can’t beat science!

For cleanroom validation and certification, contact Gergig Engineering Company. Check out the services on our website for more information or contact us at: 888-628-0056; info@gerbig.com.

Cleaning the Components in Electronics Manufacturing: Part 2

More options for cleaning electronic components and maintaining a cleanroom for electronics manufacturers.

When electronic components are exposed to humidity or fluctuating temperatures, protective layers can erode, thereby releasing ionic substances. The risk of electro-migration and dendritic growth makes cleaning electronics in these environments necessary. In part 1, we covered solvent options. Here we will explore water-based media.

Ultrasound cleaning with water-based media offers practical solutions to electronics manufacturers. The electrical signals from the ultrasound influences the cleaning action for the cleansing agent. The lower the frequency, the more energy is released by sound waves. Cleaning tests will help you figure out the right combination of cleansing agent and ultrasound frequency.

Carbon dioxide offers a nice dry alternative. Compressed carbon dioxide possesses excellent properties as a solvent on nonpolar impurities like grease and oil. With low viscosity and interfacial tension, supercritical CO2 has a strong capacity for penetrating crevices. This works well for small, drilled holes and other complex geometries. This environmentally-friendly, dry, residue-free procedure can clean complete PCBs and assemblies.

The chemical, thermal, and mechanical properties of CO2 snow-jet cleaning removes surface films and particulate contamination without leaving residue. This type of cleaning can be used on contact points, in preparation for bonding processes, equipping PCBs and foil-PCBs, and manufacturing of metal-insulator semiconductors.

Plasma is another medium used to clean electronics. The physical and chemical reaction during the cleaning procedure allows plasma to efficiently surface treat parts and components while cleaning away organic impurities like oils and grease and activate the surface. Depending on the application, low-pressure plasmas or inline-capable atmospheric pressure plasmas can be used.

For all water-based media, solutions will depend on your plant technology as well as the components that need cleaning. For other cleanroom solutions, like certification, validation, and modular construction, contact Gerbig Engineering Company. Our experts understand compliance and electronic manufacturing: 888-628-0056; info@gerbig.com.

Cleaning the Components in Electronics Manufacturing: Part 1

Electronic components in adverse environments require careful cleaning to remain compliant. This series explores the means of doing so.  

Thanks to no-clean fluxes and soldering pastes, the need to clean components in electronics manufacturing has decreased significantly. However, this is only the case for components used in non-critical atmospheric environments. Adverse environments, like humid or fluctuating temperatures, can erode the protective layer applied in the no-clean process. This releases ionizing substances that promote electro-migration and dendritic growth. You’ll find this in narrow spaces under components and between connections and contact surfaces. Additionally, fluxes, residues of soldering agents and adhesives, and dust need to be removed from electronic components.

In choosing a cleansing agent, you need to consider the subject material as well as the nature and quantity of the impurities to remove. Cleaning agents for electronics include solvents, water-based media containing alkaline surfactants, and water-based tenside-free solutions. In this article, we will discuss solvents.

Solvents for the electronics manufacturing industry contain non-halogenated hydrocarbons, modified alcohols, or hydrofluorethers (HFEs). HFEs are the alternative to chlorofluorocarbons (CFCs), which were found to have a high potential for breaking down ozone about 20 years ago. Both have similar properties, but HFEs don’t persist in the atmosphere and pose no danger to ozone. Monosolvent, bisolvent, and cosolvent systems use these solvents.

  • Monosolvent: Using a pure HFE or azeotrope, these systems remove slight impurities like halogen compounds, particles, dust, light oils, and residue of easy-clean solvents.
  • Bisolvent and Cosolvent: Both systems combine HFE with a low-volatility organic solvent. The solubility promoter of the organic solvent removes impurities while the HFE rinses them away. These are great for stubborn impurities like wax, adhesives, heavy oils, hot-melt glues, grease, and C-flux residues. The biggest difference between these two systems is that the solvent and rinsing agent are mixed together in a cosolvent and kept separate in a bisolvent.

In part two, we will look at water-based cleaning agents containing alkaline surfectants. If your electronics cleanroom requires validation or certification, contact Gerbig Engineering Company. We excel at cleanroom applications for the electronics and pharmaceutical industries. 888-628-0056; info@gerbig.com.

Glove Protection: Three Risks People Face in a Cleanroom

What are the differences in glove needs for the various risks involved when working in a cleanroom?

Cleanrooms and cleanroom protocols are all about deliberate, diligent protection. They protect the product and materials, but most importantly, they protect people. The safety and protection of the cleanroom worker is paramount, and the glove is one of the key tools used to assure it. There are three categories of hazards from which humans need protection: physical, biological, and chemical. As far as gloves are concerned, each category yields separate, unique requirements for safety.

Physical – If you work around sharp or abrasive objects, you face a physical risk of harm. Anything that can cut, scratch, or penetrate the skin is an obvious hazard. True cut protection is only found in cut-resistant gloves that need be worn beneath cleanroom gloves. However, improvements have been made in the durability of cleanroom gloves. You may not require the sophistication of cut-resistant gloves with some of the available materials.

Biological – Aseptic manufacturing and research are common environments for biological hazard risks. Workers handle potentially pathogenic materials, usually wearing thin, single use, disposable gloves similar to surgical gloves. Barrier integrity may be tested by evaluating for pinholes. The Acceptable Quality Level (AQL) of gloves like these are determined by the manufacturer. When choosing your gloves, know that he lower the AQL, the higher quality the barrier.

Chemical – Chemicals and chemical compounds react differently to materials in gloves and to skin. Single use gloves are designed for splash protection from small quantities of hazardous chemicals. This is only enough protection to allow the person time to remove and replace the gloves should chemicals splash onto the hands.

The type of gloves you need, as well as other protective apparel, will vary by application, so know what you need protection from when ordering. If you need cleanroom validation, certification, or construction, contact Gerbig Engineering Company. We have thirty years of experience in cleanroom success. 888-628-0056; info@gerbig.com.

Continuous Availability: Disaster Planning for your Controlled Environment

If you have critical data in your facility, you need to ensure it’s protected in the face of disaster. Here is a guideline on how.

Whether it’s manmade or natural, many manufacturers with cleanroom facilities are vulnerable to disaster. Three main concerns should this occur are security, risk management, and business continuity. Should any of these be compromised, it would be catastrophic. Therefore, a disaster recovery plan is necessary to any organization with something to lose.

When thinking of continuous availability, you need a strategic approach. You want to develop scope, context, and management commitment. Following that, define all company roles and responsibilities to know every business process within the organization. Assign staff to define risks and the business impact of each.

With these things identified, you’ll be able to develop a strategy, plan, and procedure for business continuity in the face of disaster. Your technology solutions will fit into this crucial step. This complex task should include three areas:

Data protection – a number of disasters can destroy data, so protecting it needs to extend beyond onsite storage. Hosting it offsite will increase your chances of data survival in the case that the unexpected occurs. How far away the offsite storage should be is dependent upon what kind of risks you face.

System recovery – make sure you’re current on updates and maintenance for your servers, platforms, operating systems, hypervisors, networks, and backup software and hardware. You want to ensure that these systems can recover your applications.

People, processes, program – if a catastrophe occurred today and employees had to work remotely tomorrow, would they know what to do? Equip your staff with the proper training, workspace, and equipment they need to function in the face of disaster. Have a document that details the steps of your recovery. Include how to redistribute the workload across your organization. Also consider your critical suppliers – can you still operate if this happens?

You must continually test and analyze these processes throughout the year, performing mock disaster scenarios, and making improvements when necessary. There are companies that specialize in disaster recovery who can help you optimize your business continuity program. For other cleanroom needs, like validation, verification, and construction, contact Gerbig Engineering Company. Our experts understand the needs of your facility no matter the industry. Call 888-628-0056 or email info@gerbig.com.

4 Types of Modular Cleanrooms Part 2

Further discussion on the options one has for modular cleanrooms as opposed to other controlled environments.

Modular cleanrooms are a popular alternative to other kinds of controlled environments because they are convenient and reliable. In part one, we discussed two of the four types of systems. Here we will cover the remaining two.

Structural post and panel

Most modular manufacturers have a core product that acts as an “all-purpose” system. These products can be utilized for numerous applications, from particular ISO classes to GMP rooms. The versatility that these systems provide make them appropriate to outfit existing facilities or build freestanding structures to envelop separate, compartmentalized processes.

A post-panel design provides even more flexibility to these systems. A variety of wall panels and cores can be integrated to meet various needs and applications. These include: polystyrene, aluminum honeycomb, fiberglass reinforced plastic, and stainless steel.

Quality control enclosures, inspection rooms, medical device packaging areas, machinery enclosures, and USP 797 compounding labs are all examples of applications that benefit from these all-purpose cleanroom systems.

Framing and partitioning systems

These are typically the ideal solutions for applications demanding a lot of precision, like microelectronics and nanotechnology. They require systems that integrate well with the equipment used to run the operations. Framing systems feature both vertical and horizontal members that connect easily, therefore simplifying bulkheading as well as creating airtight seals around equipment. The walls can easily be removed without removing adjacent panels, ceiling grids, or framing studs.

Something to be aware of in the microelectronics industry is that cleanrooms usually require anti-static wall panels hat are non-shedding and non-outgassing. Honeycomb aluminum panels have proven to perform well, but they are expensive. More cost-effective designs are often available if you compare your needs with what manufacturers have to offer. With a little research, you could reduce the cost of your cleanroom without sacrificing functionality or performance.

Depending on your application and needs, either a softwall, aseptic, structural post-panel, or framing system will meet your modular needs. Gerbig Engineering company’s AireCell line is especially cost-effective. The aluminum and PVC extrusions are quickly installed and offer design flexibility. Contact us to discuss the AireCell systems: 888-628-0056; info@gerbig.com.

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