6100A / 6180A Paperless Graphic Recorder

6100A / 6180A Paperless Graphic Recorder
Product Description

000 Series graphic recorders offer tamper resistant data file formats, audit trail, user management and batch features for traceability of the process.

  • Functions for calculating MKT (Mean Kinetic Temperature) and Steam Flow
  • Functions for monitoring sterilization processes, including F0 calculation for parametric release
  • Password-controlled user access and electronic signatures provide event traceability for quality approvals and audits aiding compliance to FDA 21 CFR Part 11 regulation and Data Integrity ALCOA+ principles
  • Security Manager option for centralized access control
  • Can reduce capex using preset ISPE GAMP® 5 validation document templates and built in functions to meet Category 3 only
  • Secure File Transfer Protocol (SFTP) client and server for enhanced cybersecurity robustness

Watlow

  • US
  • 2023
    On CPHI since
  • 3
    Certificates
  • 1000 - 4999
    Employees
Company types
IT/Software solution provider
Machinery and Equipment Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Cleanroom Technology
Other
Technology

Watlow

  • US
  • 2023
    On CPHI since
  • 3
    Certificates
  • 1000 - 4999
    Employees
Company types
IT/Software solution provider
Machinery and Equipment Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Cleanroom Technology
Other
Technology

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Watlow resources (6)

  • Video Watlow vision for Life Sciences. We start with compliance.

    Focused on key applications and following Quality by Design (QbD) principles, we continue to invest in the development of digital engineered solutions (DES) to aid GMP, regulatory compliance and efficiency optimization and help reduce capital project execution costs, risks and time to market, as well as offering services that help lower operational expenditure.
  • Whitepaper How to Meet Data Integrity ALCOA+ Principles

    Proof that pharmaceutical ingredients and products have been made correctly and are safe to use is reliant on trustable data from the manufacturing process and its supply chain. The Data Integrity ALCOA+ concept defines best practice guidelines and methodologies for good data management within life science industries. This paper gives an overview of the ALCOA+ concept, its role within the digital transformation of the Life Science Industry, and offers a view on data acquisition and management solutions that help achieve the required data integrity
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    This document is a compendium of key European and North American rules and regulations governing environmental monitoring of storage and production in the Life Sciences industry 
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    Temperature continues to play an important role in the development of new medical equipment, biotechnology and clinical diagnostic instrumentation. With 50 years’ experience in the Life Science industries, Watlow® is a leader in breaking new ground in designing, manufacturing and supporting innovative thermal solutions to meet medical advancements and new industry requirements. Leading medical equipment manufacturers rely on Watlow solutions for their patientcare equipment, surgical devices and biotechnology and clinical diagnostic instrument application needs.


    Greater temperature responsivenessAccurate temperature control of critical processesLow leakage current complianceReduced cost, space and device weightSuperior temperature measurementLower heater mass and temperature uniformityFaster processing timesReduction in moving partsProduct miniaturization
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    Eurotherm provide a range of products, engineered solutions and services throughout the world. We can help to solve your manufacturing challenges:Development cost and time to market (data analytics and knowledge management)Constraints linked compliance (Quality by Design)Improving process efficiency (through quality and cost control)Adapting to patient centred care (personalised medicines)Target carbon neutrality 
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    ISPE guidance suggests considering the segregation of the Building management system (BMS) and the Environmental monitoring system (EMS). Segregating the control system (BMS) from the monitoring system (EMS) enables significant savings, in fact: qualification documentation and execution challenges apply to EMS only, change control and risk assessment activities are not required for modification to the BMS, periodic calibration routines are limited to the EMS, record management is limited to the EMS critical parameter data and its contextual metadata.