Newsletter | February 4, 2023

02.04.23 -- January's Most Popular Articles & Solutions
 
Featured Editorial
Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
 
By Andrew Walsh, Thomas Altmann, Ralph Basile, Stephane Cousin, et al.

ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.
FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
 
By Mark Durivage, Quality Systems Compliance LLC

The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device?
 
By Marcelo Trevino, Agendia

Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as software as a medical device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.
Top Industry Insights
The Criticality Of Process Validation
Article | By Todd Owens and Raghu Vadlamudi, Donatelle

Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.
Gamma, Ebeam, Or X-Ray? The Future Of Radiation Sterilization
Article | By Paul Priebe, Qosina Corporation

Explore gamma, Ebeam, and X-ray sterilization modalities along with comparatives studies by leading academic and trade organizations, including the conclusions they draw on sterilization techniques.
Cleaning Validation For Medical Device Manufacturing
White Paper | Alconox Inc.

Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.
Top Resources
PurSil Thermoplastic Silicone Polyether Polyurethane (TSPU)
DSM Biomedical
Catheters And Cannulae
Nordson MEDICAL
Minimizing Uncertainty Throughout The Development Life Cycle
West Pharmaceutical Services, Inc.