Displaying 1–25 of 75 results for Validation

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Special Report: Addressing Process Contamination Risks

(Whitepaper)

The high risk involved with biopharmaceuticals means there are high demands placed on the hygienic design of bioprocessing equipment. Instrument connections on equipment are a known challenge in preventing process contamination, especially when they aren’t properly installed or maintained.

Proof Testing Level Instruments

(Whitepaper)

Learn how partial proof testing of level instruments can save millions of dollars and maintain required safety ratings.

The State of Environmental Monitoring: Avoiding the Dire Risks of a Poorly ...

(Whitepaper)

This white paper contains expert insights on how to much more effectively manage Environment Monitoring in manners that increase efficiency, increase compliance and decrease risk.

eBook: Transforming Pharmaceutical Packaging, Quality & Efficiency with ...

(Whitepaper)

This eBook discusses application of machine vision technologies in pharmaceutical packaging.

Cleaning Validation Productivity: New Approaches for Recovery of Complex ...

(Whitepaper)

The goal of any cleaning validation program is to reduce the risk of product contamination by minimizing carryover on manufacturing equipment while managing budgets.

Troubleshooting Tips & Best Practices for Environmental Validation/Mapping

(Whitepaper)

The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics.

NEW eBook: Using GAMP Methodology to Select & Validate Monitoring System ...

(Whitepaper)

Learn how to use GAMP methodology to select and validate a monitoring system software.

A 9-point Plan for GxP Warehouse Mapping

(Whitepaper)

Vaisala recommends a 9-point process for successfully validating a GDP compliant warehouse or other storage space.

Cleaning Validation Video: Solubility is Important, but not a Solution

(Whitepaper)

Learn how companies can move on from solubility when it comes to cleaning validation.

Validation FAQs - Five Key Questions You Need to Have Answered in Planning a ...

(Whitepaper)

Validation FAQs - Five Key Questions You Need to Have Answered in Planning a Validation Project

Solutions Brief: Single-Use Pumps Meet Biopharmaceutical Scale-Up, Validation...

(Whitepaper)

Solutions Brief: Single-Use Pumps Meet Biopharmaceutical Scale-Up, Validation and Product Sensitivity Challenges

Thermistors and Thermocouples: Matching the Tool to the Task in Thermal ...

(Whitepaper)

Thermistors and Thermocouples: Matching the Tool to the Task in Thermal Validation

A 9-Point Plan for GxP Warehouse Mapping

(Whitepaper)

A 9-Point Plan for GxP Warehouse Mapping

Verifying the Performance of a Validated Cleaning Process Using TOC

(Whitepaper)

This executive summary from GE Analytical Instruments on Cleaning Validation Re-Imagined offers a thought-provoking approach to cleaning validation and verification. Although detecting residues has focused on using a product-specific method in the past, what if you looked at the process instead?

New USP Sterile Water Testing Requirements

(Whitepaper)

On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to ...

Validation of Manufacturing Execution Systems

(Whitepaper)

Manufacturing execution systems (MES) are increasingly commonplace in pharmaceutical manufacturing environments and they can be interfaced with many types of systems, equipment and instruments. Controlling the manufacture of pharmaceutical and medical products is critical to ensuring product ...

Smart Camera Vision Systems: The New Approach to Track and Trace

(Whitepaper)

Increasing global regulations on healthcare products have many pharmaceutical manufacturers preparing to implement serialized packaging in support of full traceability and authentication requirements.

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

GMP Warehouse Mapping: Step-by-Step Guidelines for Validating Life Science ...

(Whitepaper)

This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs-including many that have been published or revised recently. It draws on Vaisala's extensive experience in environmental and industrial measurement and monitoring throughout over 150 countries.

Smart Camera Vision Systems: The New Approach To Track and Trace

(Whitepaper)

Increasing global regulations on healthcare products have many pharmaceutical manufacturers preparing to implement serialized packaging in support of full traceability and authentication requirements. However, the traditional approach of deploying turnkey serialization solutions that integrate ...

Biopharmaceutical Process Scale Up: Get It Right

(Whitepaper)

Scaling up any biopharmaceutical process requires a clear understanding of both "real world" and laboratory conditions. Success ultimately depends on close process monitoring, and sensitive and accurate sensors.

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

Thermo Scientific TruScan Fast, Cost-Effective Method Development

(Whitepaper)

Thermo Scientific TruScan is a rugged, handheld system for rapid material verification. On-the-spot results are delivered in seconds with nondestructive point-and shoot sampling through sealed packaging. TruScan reduces the need for quarantine areas and staging of raw materials, while minimizing ...

The Executive Guide to Contracts & Chargeback Management

(Whitepaper)

When it comes to un-validated chargebacks the stakes are and can quickly erode the manufacturer's margins and quickly amount to significant financial loss. Time pressures, transaction volume, and requirements for data accuracy combined to make managing chargebacks a significant challenge for many...

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