New USP 800 Compliance White Paper

New USP 800 Compliance White Paper

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.

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Electrical Package for Cleanrooms Now Available from Simplex

Electrical Package for Cleanrooms Now Available from Simplex

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.

new modular cleanroom electrical package illustration

“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.”

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Simplex Announces The Addition Of A New Customer Service Representative

Simplex Announces The Addition Of A New Customer Service Representative

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

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Thermal Efficiencies in Refrigerated Transporter

Thermal Efficiencies in Refrigerated Transporter

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.

Read the full article at Refrigerated Transporter

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