Compliance
PRODUCTS
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Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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Isolators are a core component to the pharmaceutical industry critical for a range of processes. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment.
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The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.
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Maximize productivity while meeting regulatory requirements.
Finally, an ISO 17025 accredited service for automated liquid handlers–so your team can stay focused on what they do best.
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Single-Use System
The U2k® single-use centrifuge is the scaled-up version of our successful UniFuge Pilot product. It uses gamma-irradiated, single-use modules to eliminate cleaning needs. It is designed for primary clarification of mammalian cell cultures (e.g., CHO cells) and harvesting (including washing and concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications.
- Bowl capacity: up to 9 L
- Flow rate up to 20L/min (5 times the flow rate of the UniFuge®.
- Small footprint: 80 cm x 206 cm x 200 cm high (31” x 81” x 78”)
- Easily movable with stainless steel casters leveling on skid with vibration isolators
- Gamma-irradiated single-use modules
- Scale processes down with the UniFuge® Pilot and UFMini®
WHITE PAPERS AND CASE STUDIES
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Successfully Delivering Critical Stem Cell Samples Across The Globe
To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.
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Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Cabrini Health Experiences Improved Operational Efficiency And Other Significant Benefits With triCerat
Cabrini Health is a not-for-profit Catholic healthcare service with 3,800 employees and over 700 beds comprising of two acute care hospitals, a palliative care service, rehabilitation hospital, residential care facility, and pharmacy department.
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Payment Card Industry Compliance: Are Companies Really Compliant? The Payment Card Industry Data Security Standard (PCI DS ) is a multifaceted document with 12 security sections and more than 250 individual requirements contained in the supporting detailed audit procedures. Even the most established and capable Level 1 merchants have trouble translating all the requirements in order to become 100 percent PCI-compliant. By Protiviti Inc.
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How To Make Enterprise Mobility Manageable
This CITO Research white paper sponsored by Fiberlink discusses what is needed beyond mobile device management (MDM) to achieve true enterprise mobility.
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Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
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Sporting Goods Retailer Takes Safety And Product Testing To A New Level
This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
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Considerations For Designing, Implementing, And Managing An E-Mail Archive Solution Email has become an essential business tool, through which employees and management communicate. Beyond this, email is also embedded in many critical corporate processes. Unfortunately, most organizations are finding it quite difficult to keep pace with the enormous data growth rates of their email systems. This has a dramatic, rippling effect on the efficiency and effectiveness of these organizations. Submitted by Symantec Corporation
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PCI Compliance Case Study: Wesco Convenience Stores Tripwire® Enterprise’s configuration control solution specifically addresses many PCI requirements and provides auditors with comprehensive reports that prove effective risk control. Tripwire detects and documents all changes so that IT staff can quickly troubleshoot any service incident, and return systems to a known state. By Tripwire, Inc.
NEWS
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Jamf Teams With Google Cloud To Enable Collaborative, Mobile Workforces Through New Advanced Security And Management Workflows7/6/2023
Jamf, the standard in managing and securing Apple at work, announced three new integrations with Google Cloud, enabling and protecting mobile workforces that use Google and Apple.
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Cellares Unveils First cGMP Compliant Cell Shuttle In Its South San Francisco Center Of Excellence3/12/2024
Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, today announces the completion of its first current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle.
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Semitech Delivers Support For Transportation Platforms With Turnkey PLC4TRUCKS Module, J2497 Compliant Chip2/23/2023
Semitech Semiconductor, an innovative provider of reliable wireless and power line communication (PLC) solutions for smart grid, automotive and industrial IoT applications, today announced that its SM2400 solution now supports the SAE J2497 (PLC4TRUCKS) standard.
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Selkirk Pharma Announces New APS Qualified Facility With Advanced Fill/Finish Capacity In Spokane, WA2/15/2024
Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity.
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Rohde & Schwarz Launches New EMI Test Receiver For Emission Measurements Up To 30 MHz At The EMV 2023 In Stuttgart3/23/2023
Rohde & Schwarz demonstrates the new R&S EPL1000 EMI test receiver for reliable certification measurements with minimum test times at EMV 2023 Stuttgart.