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New Modular Cleanrooms Catalog available from Simplex

New Modular Cleanrooms Catalog available from Simplex

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.

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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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