ARTICLES BY TIM SANDLE

• Designing Facility Monitoring Systems For Cleanrooms

  12/4/2023

  Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

• New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

  9/11/2023

  The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

• CGMP Requirements For Automated Facility Monitoring Systems

  8/15/2023

  To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

• FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity

  7/18/2023

  The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

• Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

  7/6/2023

  The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

• FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors

  5/23/2023

  An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

• Not All Plate Counting Technologies Are The Same

  5/18/2023

  While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.

• 5 Characteristics Of The Automated Microbiology Lab Of The Future

  4/24/2023

  The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

• Tackling Safety Issues Of Adjuvanted Vaccines

  3/8/2023

  An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.

• FDA Adopts ICH Final Guidance On Bioanalytical Method Validation

  1/11/2023

  The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.