Simplex Isolation Systems has launched a new 2017 Modular Cleanrooms catalog. The catalog highlights the company’s complete suite of hardwall and softwall enclosures in addition to illustrating a continued commitment to innovation, quality and being an industry leader in the development of modular, expandable and high-performing cleanrooms.
The 32-page catalog is formatted for easy product look-up and contains an abundance of comprehensive material and insight from Simplex’s expert team. Most notably, the catalog encourages exploration through:
- Detailed Content: Specifications and key features on Simplex’s key cleanroom lines, including the SIS 797 Hardwall Cleanroom, AirLock Cleanroom and SIS 212 Softwall Cleanroom.
- New Product Launches: Including Simplex’s Twist-Lock Cleanroom Electrical Package and standard cleanroom floor plans.
- Educational Material: Convenient configuration selection guides, ceiling component breakdown recommendations, custom cleanroom design guides and more.
In the user-friendly catalog, users can explore the cleanroom that best suits the needs of their specific application and gain comprehensive insight from Simplex’s Environment Control Experts on the benefits of choosing modular.
Visit our Resources page to download the catalog.
New white paper explores the facilities challenges of USP 800 compliance and provides considerations to overcome them
Simplex Isolation Systems has announced a new white paper that explores the challenges imposed by USP 800 Section 5: Facilities and Engineering Controls. The white paper was developed to help healthcare institutions understand the necessary upgrades and modifications required of their facilities to achieve USP 800 compliance. Additionally, the white paper provides these organizations ways in which they can leverage their current facility layout and infrastructure to keep modifications within budget.
The US Pharmacopeial Convention (USP), a non-profit organization that sets health care activity standards enforceable by the Food and Drug Administration (FDA), adopted the USP General Chapter 800 regulation in February 2016 to address concerns over the handling of hazardous drugs. The regulation identifies the requirements for the receipt, storage, compounding, dispensing and administration of hazardous drugs to protect the patient, healthcare personnel and environment. It includes both non-sterile and sterile products and preparations and the standard applies to all personnel who compound these drug preparations and all places where they are prepared, stored, transported and administered.
Titled, “Considerations on Facility and Engineering Controls in the Wake of USP 800”, this white paper provides an overview of USP 800 Section 5: Facilities and Engineering Controls.
Key topics that are discussed include:
USP 800-compliant space configurations for receipt, unpacking, storage and compounding of hazardous drugs.
Optimal space layouts for non-sterile and sterile hazardous drug compounding rooms.
Modular versus traditional stick-built secondary engineering control rooms.
Typical facility infrastructure challenges and potential solutions recommended for compliance.
“Since the publishing of USP General Chapter 800 in 2016, we have seen a trend in the configuration, building and infrastructure challenges that our customers have been faced with,” stated Darren McKinnon, Critical Environment Specialist at Simplex and key contributor to the white paper. “Our goal for the whitepaper was to define all potential difficulties from a building design standpoint in one educational piece that healthcare institutions can reference when planning for USP 800 compliance.
From our article in Data Center Frontier, the leading source of information on data centers and cloud computing:
Ward Patton, Critical Environment Specialist at Simplex Isolation Systems, unpacks five key considerations for airflow containment design.
Data center containment systems can provide great benefits over traditional open data center designs. By implementing an effective airflow containment strategy, it is possible to see optimized cooling system efficiency, improved Power Usage Effectiveness (PUE) and additional equipment capacity, all without having to expand a facility’s footprint.
Like any successful system, airflow containment design must consider many different factors to ensure a solution that achieves the required cooling, while remaining flexible for expansion or changes and integrates well with the current infrastructure. Here are five key considerations to keep in mind when planning a data center containment project.
1. Hot Aisle or Cold Aisle Containment
Hot air and cold air containment are the two high-level methods of an airflow containment strategy, and there is an ongoing discussion in the industry about whether it makes more sense to isolate the hot aisle or the cold aisle. Different data center experts advocate different theories, but realistically, the approach should be dictated by the existing infrastructure.
For example, what is the current air distribution type in the facility? This will play a critical role in deciding which approach is the best fit. Data centers with targeted return and flooded supply air distribution would benefit more from hot aisle containment, whereas data centers with targeted supply and flood return air distribution would see better results with cold aisle containment.
Additional factors that can dictate whether to isolate the hot aisle or the cold aisle include the depth of the raised floor plenum, the presence of overhead cabling, varied ceiling heights and support column locations. These are only some of the infrastructure constraints that need to be addressed and every case is site specific. An assessment of the existing conditions of the facility is essential to choosing the right containment solution for any data center.
2. IT Equipment Arrangement
Once the infrastructure has been evaluated, the next step is to review the current IT equipment arrangement. While most data centers are depicted having rows and rows of server racks of the same brand, shape and size, this is rarely the case. It is not uncommon to see offset rows consisting of multiple server rack brands in all number of shapes and sizes. This is especially true for legacy data centers that have undergone expansion, or are the result of the consolidation of multiple facilities.
It is also recommended to go one step further and review any ergonomic challenges. Factors such as clearance or personnel traffic should be reviewed and planned for accordingly. End-of-aisle doors for instance, should be configured to best fit the traffic patterns within the data center making the space easier to work in when moving racks and other items in and out.
When evaluating an airflow containment system, it is critical to assess the amount of customization that will be needed for the containment system to perform optimally, especially if there is a lack of uniformity with the IT equipment. While it may seem daunting to find a containment system that can accommodate all levels of variation, most innovative manufacturers can offer a customized and flexible solution to fit any new or retrofit application.
3. Fire Detection and Suppression
Fire suppression in the data center is complicated and involved. It is a good policy to involve the local Fire Marshal as soon as possible when planning an airflow containment system. The Fire Marshal enforces the local codes and standards in the jurisdiction and can play a critical role in providing the insight needed to achieve compliance from the very beginning.
Jurisdictions will require compliance with the National Fire Protection Association (NFPA) 75 and 76, which ensure that fire suppression systems are in place and meet specific testing requirements. From a containment standpoint, these standards require data center facilities who use an airflow containment system to either have a fire suppression system that covers all areas of contained aisles or a containment system that integrates with the fire detection system. The former option can be a costly and daunting task, so many data center managers will opt for a containment system that works with the current fire suppression infrastructure.
There are many reputable containment systems available today that are designed specifically for use under a fire suppression system, though potential implications associated with the containment approach will still need to be considered. Vertical containment systems that incorporate softwall curtains, for example, would need to account for the required clearance space below the sprinkler level if the facility is equipped with a sprinkler-based fire suppression system. This would insure full dispersal of water in the event of a fire. Such systems would also need to consider what softwall material is being implemented. It’s not uncommon to receive demands from the Fire Marshal to source curtain materials that meet the stringent ASTM E-84 Class 1 rating for flame and smoke generation, so researching and selecting an appropriate softwall material is important.
Systems that feature ceiling partitions rather than softwall curtains will need to address how the facility’s fire suppression system will be accommodated. These structures generally include ceiling panels that are retractable, are equipped with a soft drop system, or are designed to shrink and fall away when exposed to temperatures that reach 15 to 20 degrees lower that the temperature at which the fire sprinklers would activate.
Whatever the containment approach, there are additional factors to consider when evaluating which system is the best fit:
A fail-safe system is key. Look for a containment system equipped for a facility power outage or Emergency Power Off (EPO) event. While many systems may tie into a dedicated emergency back-up supply, relying on a supplemental power system can’t be deemed fail-safe. Instead, consider a system that is inherently fail-safe, such as a gravity-reliant, electromagnetic droplink that would drop away when the power source is disconnected. That way the fire suppression system would still operate successfully in the event of a power outage.
Consider equipment and personnel safety. Look for a system that won’t cause additional damage to equipment or prove harmful to personnel if deployed. Curtain systems for instance, should be equipped with a lanyard drop system and ceiling structures should retract or have a soft-drop feature to prevent damage when they are utilized.
Testability. Look for a system that can be tested and reset in the event of deployment. This is a requirement for NFPA 75 compliance.
4. Electrical Utility Incentives
There is a good chance that your electrical utility provider has a system of rebates and incentives for companies that take proactive measures to decrease power usage in their data centers. The utility might have certain stipulations in place such as approved contractors, approved equipment and other requirements. Take these considerations into account as you begin the design process, rather than after the airflow containment project is underway. There are often specific time windows to take advantage of these incentives.
5. Future Growth
Understand that change is unavoidable and design the airflow containment based on that reality. Eventually changes in the data center will be required to accommodate growth or reconfigure the layout. When evaluating an airflow containment system, it makes sense to look for components and structures that are modular in design. Modular mounting hardware for curtains and modular end-of-aisle doors, for example, can be relocated or expanded upon if needed. Ultimately, containment systems that are modular in design will have a lower cost of ownership.
Overall, data centers are complicated and there are many factors that come into play when designing an effective airflow containment solution. When making plans for airflow containment, it is recommended to work with reputable manufacturers that can analyze the space and align airflow and containment objectives with the data center’s site-specific infrastructure and equipment requirements to secure the greatest efficiencies and enable modular, scalable and affordable growth.
Ward Patton, Critical Environment Specialist at Simplex Isolation Systems, has over 15 years of experience helping customers in the data center space align airflow and containment objectives with their site-specific infrastructure.
Simplex Isolation Systems designs and manufactures custom data center containment systems that are modular, expandable and high-performing. Simplex’s Containment Resource Guide can serve as an essential tool for planning a hot or cold aisle containment system.
Visit our team at this year’s Data Center World Global April 3-6, 2017 at booth # 1027. Use promo code DCWGSAVE25D for 25% off an All Access Pass or Standard Pass
A convenient “Twist-Lock” electrical wiring package is now available from Simplex Isolation Systems to outfit new SIS-797, SIS-212 and AirLock enclosures with everything needed for quick utilization after installation. Unlike traditional hard wiring methods which require extensive involvement from electricians, Simplex’s “Twist-Lock” pre-engineered package can be quickly and easily locked together by the enclosure installers—requiring an electrician only for the final service connection.
“The electrical package can be 100% customized to meet the needs of the enclosure’s application,” said Jason Steele, Product Development Manager for Simplex Isolation Systems. “For example—equipment placement, counter heights and voltage requirements are all taken into consideration and accommodated for when designing electrical outlet or switch placement.”
Simplex offers pre-engineered “Twist-Lock” electrical wiring for components such as lights, HEPA filters and electrical outlets. All switches, outlet boxes and wiring fit neatly into Simplex’s standard framing system for a clean, professional look. All wiring is brought to a convenient distribution box atop the enclosure where an electrician can finish the installation by connecting the single point connection to a power source.
Notable benefits of the electrical package include:
- Cost – Fast and easy installation without an electrician lowers overall labor costs.
- Versatility – Modular wiring can be reconfigured and reused if a change to the enclosure is made.
- Reliability – “Twist-Lock” technology ensures secure electrical connections.
- Time – Complete electrical package reduces the total time needed for installation.
- Convenience – “Twist-Lock” electrical connections securely lock together, allowing installation while the enclosure is still being assembled.
“After receiving a great deal of demand for custom electrical wiring to outfit our cleanrooms and enclosures, we are pleased to announce the addition of our “Twist-Lock” electrical package to our list of value-added services,” said Steele. “The custom-built feature coupled with the benefits of cost reduction and time savings have made our distributors and end-users very happy.”
Recently, Simplex Isolation Systems attended the PCCA International Seminar in Houston, TX. Not surprisingly, the hot topic of the event was the recently adopted US Pharmacopeial Convention (USP) regulation, USP 800, which addresses concerns over the handling of hazardous drugs in healthcare settings. As an update to current compounding standards, this regulation incorporates information contained in USP 795 and 797 and adds the element of containment of Hazardous Drugs.
The regulation seeks to “identify the requirements for receipt, storage, compounding, dispensing, and administration of hazardous drugs (HDs) to protect the patient, healthcare personnel and environment.” Overall, the philosophy is that there is no acceptable level of exposure to hazardous drugs and that exposure should be limited to the lowest possible level by using engineering controls and personal protective equipment. The latest revision of USP 800 can be found here.
While it’s clear that USP 800 is an important step in protecting healthcare workers and the environment, it is also clear that there is some confusion on what USP 800 actually means for cleanroom design and functionality. During the PCCA International Seminar, our Critical Environmental Specialists were asked many questions about the modifications needed to make current cleanrooms USP 800 compliant before the July 2018 implementation date. Others asked what USP 800 means for their future cleanroom designs.
With the abundance of questions being asked, we wanted to take the opportunity to answer the most frequently asked questions to clear up some of the confusion.
The 5 Most Asked Questions About Cleanroom Design in the Wake of USP 800:
1. Regarding the requirements for C-PECs (Containment Primary Engineering Controls) and negative pressure rooms, what are the key differences between USP 797 and USP 800?
A lot of the regulations are congruent because USP 800 is meant to work conjointly with USP 797. There are a few exceptions, however, and USP 797 is expected to be updated with these new changes in the future.
In regards to USP 800, the regulation states that the negative pressure room has to be between 0.01 and 0.03 inches of water column more negative than the surrounding areas. USP 797, on the other hand, does not have an upper limit.
It is also a requirement of USP 800 for C-PECs to be located within a negative pressure room for all hazardous drug work. This does not have to be a CACI (compounding aseptic containment isolator).
The last difference is that all hazardous drug work needs to be done in a C-PEC.
2. Is a positive pressure ante-room required in a non-sterile hazardous compounding cleanroom per USP 800 regulations?
No. Non-sterile hazardous drug C-SECs do not require a positive pressure ante-room. It is a requirement, however, that they be physically separated from other areas, with negative pressure of 0.01-0.03 inches of water column relative to surrounding areas, as well as 12 ACPH. Refer to Figure 1 below.
3. Do C-SECs (Containment Secondary Engineering Controls) have to have HEPA (high-efficiency particulate air) filtered external exhaust?
The original draft of USP 800 did require that C-SEC rooms be externally vented through HEPA filtration. However, Section 5.3 FACILITIES AND ENGINEERING CONTROLS, Compounding has since been revised to indicate that C-SECs used for sterile and nonsterile compounding must be externally vented, but do NOT need to be vented through HEPA filtration. The official announcement of the change to USP 800 can be found on the USP website here.
4. Can the negative pressure be greater than 0.03” of water column?
No. USP 800 states that the C-SEC, or room in which the BSC (biosafety cabinet) is located for hazardous drug preparation, must be between 0.01 and 0.03 inches of water column more negative than the surrounding areas.
5. Can the hazardous drug C-SEC, or room, be accessed through an ISO Class 7 clean room where non-hazardous drug sterile compounding occurs under positive pressure?
Yes. While the non-hazardous drug room is under positive pressure, the hazardous drug room needs to be 0.01-0.03 inches of water column more negative than the non-hazardous drug room, as illustrated in Figure 2. Both rooms need to be ISO Class 7 and have 30 ACPH. Note that this configuration has a restriction on the BUD (beyond-use date) which is outlined in USP 797. USP 800, Appendix 2, denotes this to be typically used in oncology clinic settings.
Have more questions about USP 800 and your cleanroom design? Contact a Simplex Critical Environmental Specialist today.
As a leader in USP 800 cleanroom technology, Simplex has the expertise required to design, engineer and construct your USP 800 cleanroom. Simplex products are distributed in the U.S. and Canada through a nationwide dealer network. Contact us to learn more.
Simplex Isolation Systems announced that it has appointed Andrew Hawk as the Company’s newest Customer Service Representative. Based in Simplex’s Fontana, CA facility, Andrew will be chiefly responsible for upholding customer rapport and providing exceptional customer interface support. In this position, he will work closely with customers and fellow team members to ensure the superior customer service for which Simplex is known.
Andrew joins Simplex after studies in Business Administration at Riverside City College. His commitment to providing efficient and responsive customer service, coupled with his attentive problem solving skills, make him a great fit for this position.
Poised for the role, Andrew brings with him several years of experience working in customer support positions. “I am thrilled to join the Simplex team. Through my continuous strive to provide the highest quality customer service, I hope to become a valued asset to the customer service team.”
“Andrew’s new appointment is key to insuring that we continue to improve our organizational responsiveness to our customer base,” said Larry Buck, Simplex General Manager. “Simplex has built a well-deserved reputation for excellent customer service. We look forward to utilizing Andrew’s customer service talents to uphold that reputation.”
For decades the idea of running a hot or warm data center was unthinkable; driving data center managers to create a ”meat locker” like environment – the colder, the better.
Today, the idea of running a warm data center has finally gotten some traction. Major companies like eBay, Facebook, Amazon, Apple, and Microsoft are now operating their data centers at temperatures higher than what was considered possible only a few years ago.
Why? And more importantly… How?
The “why” is easy.
For every degree the set point is raised, the cost of cooling the servers goes down 4%-8% depending on the data center location and cooling design. Additionally, some data centers can take advantage of free cooling cycles when the server intake temperatures increase. This is of course taking into account the manufacturers recommended temperature settings, and not surpassing them.
Now on to the “how”. Or we might ask why now? What changed?
The answer has to do with the ability to provide a consistent server intake temperature. Inconsistent intake temperatures are a result of return and supply airflows mixing. When this happens it creates “hot spots”, which causes cooling problems. Without a consistent supply temperature the highest temperature in those “hot spots” would determine the data center cooling set point temperature, resulting in a lower set point.
A few years ago containment was introduced to the data center industry. Containment fully separates supply and return airflow, which eliminates “hot spots” and creates a consistent intake temperature. Containment is the key to accomplishing consistent intake temperatures. With consistent intake temperatures data center managers can increase cooling set
Efficient Cooling Relies On Ensuring Proper Airflow & Preventing Air From Mixing
Cooling is always a hot topic in data centers because it is essential to ensuring the operational efficiency of your equipment, but it can also contribute to higher operating costs if not done correctly. Hot aisle/cold aisle containment is a popular approach to cooling that aims to not only improve efficiency but also maximize your overall cooling investment. Here are some ways to either develop a hot/cold aisle strategy or improve your existing approach.
Balance the Airflow
Airflow balance is another key aspect of cooling efficiency. Ward Patton, critical environment specialist at Simplex Isolation Systems (949-939-0412), equates the process to pouring a liquid from a pitcher into a pint glass. “You have all of this excess, and what’s happening is that if you don’t balance the airflow, you’re using way too much air conditioning for the area that you’re trying to cool.”
Overcooling can lead to inefficiency and higher costs, but by making some small tweaks, you can improve performance. “Once you implement the hot aisle/cold aisle containment, you build instant redundancy into the air conditioners that you have,” Patton says. “If you’re already getting it done with what you’ve got, you’re going to be ultra-efficient and have a backup for some type of catastrophic failure.”
Every data center is different. Hot aisle/cold aisle containment should be considered for almost any data center, but the layout may be different. “Take a hard look at your facility,” says Ward Patton, critical environment specialist at Simplex Isolation Systems (949-939-0412; www.simplexstripdoors.com). “If you have a facility that has a 16-foot ceiling, you don’t want to do a hot aisle in there because it doesn’t necessarily make a lot of sense. But if you have an 8-foot drop ceiling and can use that area between the drop ceiling and the hard deck, you can use that to recirculate the air back down to the air conditioning.”
(Edited and reprinted with permission from Processor Magazine)
From Our article in Controlled Environments
From our article in Controlled Environments, The leading source of information on cleanrooms and controlled environments:
“Eugean Hacopians, a recognized expert on data center design for efficiencies and cooling, drew a record crowd at the AFCOM Chapter meeting on May 12, at the offices of nGenX, in Brookfield, WI. The event was sponsored by Simplex Isolation Systems, designers and manufacturers of the AirBlock line of data center curtains and partitions for effective hot aisle/cold aisle isolation. Hacopians is the senior systems engineer at the Infrared Processing and Analysis Center, a NASA project based at Caltech in Pasadena, CA. Because so much of what Hacopians does involves storing information in data centers, he has developed expertise in data center operations. He founded ARNETech to carry that information to other data center managers.”
Hacopians’ presentation emphasized a holistic approach to designing data centers. “As computer engineers we were concerned with computer cycles, memory usage and input and output,” said Hacopians. “What we didn’t pay attention to was the sheer volume of heat generated by the processors in these data centers. We just poured in more air conditioning.”
“But energy costs are expected to double in three years,” Hacopians added. “Carbon dioxide emissions from electricity used by computers accounts for 2% of all emissions worldwide. There is a limit to how much power is available for data centers.”
Hacopians emphasized that the solutions revolve around power utilization and distribution, CRAC unit efficiency, air flow, rack placement within the data center, hardware placement within racks, and effective hot and cold aisle isolation.
“Hacopians recently worked with Simplex at Caltech to install a hot and cold aisle isolation system in a data center using the AirBlock line of data center partitions,” said Duane McKinnon, president of Simplex. “The result of that project was a 50% decrease in air conditioning requirements and a substantial increase in system stability.” “Hot aisle/cold aisle isolation is an important part of reducing the energy needs of data centers,” said Hacopians. “Simplex is doing this better than anyone out there. But they also understand that data centers are like a living organism. They are very complicated and many components and factors come into play. Good data center management requires a holistic approach that takes into consideration all factors.”
From our article in Refrigerated Transporter
From our article in Refrigerated Transporter, the information source for those involved in the transportation and distribution of refrigerated products:
The Southern California facility of Chef’s Warehouse, located in the City of Industry, made some modifications that resulted in significant operational efficiencies. It placed strip doors on both ends of the facility’s almost 1,500-square-foot freezer compartment, and on the doors to its 38,000 square feet of temperature-controlled storage space… Within a few days of installation of the ArmorBond strip doors, the average temperature in the meat freezer dropped from 29.4° to 26.7°F, with no change in the set temperature on the thermostat. A similar temperature drop occurred in the temperature-controlled storage area.
ArmorBond doors are designed and manufactured by Simplex Isolation Systems in nearby Fontana. “That’s a huge savings in energy for Chef’s Warehouse,” said Vince Iulianello, executive general manager of the company’s City of Industry facility.
Iulianello points to additional savings on the front end. He originally contemplated installing automatic freezer doors on both ends of the freezer room at a cost of $15,000. The entire package of ArmorBond strip doors, two strip doors on either end, came in for a price tag of $4,000.
Several weeks after installation, an auditor from Southern California Edison, the local electrical utility, came through the warehouse and spotted the strip doors. After a few calculations, the auditor told Iulianello that the installation qualified for a rebate equal to more than 25% of the cost of the strip doors.
“That was an added bonus,” said Iulianello.
Another benefit is the saved traffic time through the strip doors.
“The Simplex ArmorBond strip doors are designed to allow easy two-way access from not only pedestrians, but from heavy pallet jack and forklift traffic,” said Iulianello.