Compliance
PRODUCTS
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Enabling organizations of all sizes to transform their business through better use of technology.
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When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the Hull i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.
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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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Providing around-the-clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk.
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Single-Use System
The UFMini is a single-use centrifuge designed for primary clarification of mammalian cell cultures (i.e., CHO cells), and harvesting (washing & concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications. This user-friendly system is the scaled-down version of our successful UniFuge® single-use centrifuge. The UFMini is intended for use in cleanrooms, in laminar flow hoods, and on benchtops.
- Bowl capacity: 300mL
- Flow rate from 29-1,000 mL/min
- Small footprint: Centrifuge Enclosure 69 cm x 56 cm x 38 cm (27” x 22” x 15”)
- Easy to handle: Total skid weight of ~40 kg (90 lbs)
- Gamma-irradiated single-use modules
- Processes scalable to UniFuge® Pilot and U2k®
WHITE PAPERS AND CASE STUDIES
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LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
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Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
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An Equitable Way To Meet On-Site Business Needs
Tackling high turnover and employee equity challenges is a priority. Learn how an on-site insourcing solution can provide a stable and motivated team, ensuring project success.
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Osmolality: A Powerful Tool In Bioprocessing
Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.
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Client Story: Efficiency Enabling CSV At Scale
Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.
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Pharma And Biotech: How Labs Achieve Data Integrity
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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A Survival Guide To Temperature Data In Life Sciences
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
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Advancing Compliance And Digital Strategy To Align With Pharma 4.0
AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.
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Case Study: 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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Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
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Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
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Preparing For Post-Market Clinical Follow-Up Under EU MDR
Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.
NEWS
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AppTec360's Advanced Mobile Content Management Solutions Reinforce Enterprise Security3/11/2025
Data security remains a critical concern for organizations as the risk of breaches and unauthorized information sharing continues to rise. Addressing these challenges, AppTec360 introduces ContentBox, a Mobile Content Management (MCM) solution designed to enhance security while enabling seamless file synchronization and controlled data access.
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Gnosko Launches RFID-Integrated Chain Of Custody Platform To Help Labs Do More With Less5/20/2025
As laboratories face shrinking research budgets, government funding cuts, and increasing compliance demands, Gnosko is stepping up with a timely solution: a cost-effective, RFID-integrated Chain of Custody (CoC) platform that automates sample tracking, inventory management, and regulatory reporting.
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VIVEbiotech Secures Growth Investment From Ampersand Capital Partners To Expand Lentiviral Vector Development And Manufacturing Capabilities12/4/2024
VIVEbiotech, a leading lentiviral vector Contract Development and Manufacturing Organization (CDMO), today announced a growth equity investment from Ampersand Capital Partners (“Ampersand”), a private equity firm specializing in the life sciences and healthcare sectors.
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BlueFletch Pioneers Integration With Microsoft's QR Code + PIN Authentication For Frontline Workers2/25/2025
BlueFletch, a leading provider of secure enterprise mobility solutions, announces its pioneering integration with Microsoft's QR Code + PIN authentication method.
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With Click Rate Analysis, The R&S EPL1000 EMI Test Receiver Is The Cost-Effective Answer To CISPR 14-1 Compliance Testing3/1/2024
For both device developers and conformance test houses the R&S EPL1000 EMI test receiver offers fast, accurate and reliable EMI compliance measurements up to 30 MHz at the best price in its class. The R&S EPL1000 now adds click rate measurements in line with the latest CISPR 14-1:2020 version, mandatory for household appliances and electric power tools.