A systematic approach for the evaluation, validation, and implementation of automated colony counting systems

Automated colony counting systems have been available for several years with varying degrees of automation. Sophisticated instruments are now increasingly used in microbiological laboratories of pharmaceutical quality control and, in addition to the colony counting device, they are now equipped with robotic systems performing the entire handling of the Petri dishes.

 

These systems mean the subjective evaluation of microbial enumeration tests by analysts is replaced with a more accurate and precise process, which leads to significant improvements to data integrity compliance. Automated systems can also enable cost reductions in the microbiological laboratory, e.g., by not requiring a second analyst's contemporaneous verification. They also allow the direct integration of count data into a Laboratory Information Management System, reducing hands-on times, costs per test, and preventing human errors caused by manual transcription.

 

Altogether, these instruments will lead to improved monitoring and assurance of the control of biopharmaceutical processes and manufacturing environments and shortened cycle times in the supply chain. Regulators are encouraging the biopharmaceutical industry to adopt these innovative systems.

 

However, there is no standard approach taken when using these automated systems.

 

This paper describes a systematic nine-step approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of their numerous benefits.

This deliverable has been published via the PDA website.

Read the full publication
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Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

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The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

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MediPhorum

Introducing MediPhorum
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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

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Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
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Introducing the new MediPhorum
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Deliverables Report
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BioPhorum Deliverables Report
BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
Information Technology
Digital integration of sponsor and contract organizations
Digital plant maturity model
IT for cell and gene therapies
Lab of the future
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