ARTICLES BY TIM SANDLE

• 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.

• 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.

• 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.

• 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.

• ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products

  12/8/2022

  Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

• FDA Releases Guidance On Drug Products Containing Nanomaterials

  11/18/2022

  In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

• 3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations

  1/28/2022

  Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.

• Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications

  10/22/2021

  While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.

• Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity

  8/18/2021

  The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

• What To Expect From A Remote Inspection -- & How To Navigate It

  7/23/2021

  Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.