Ciba submits antimicrobials master file

Published: 30-Nov-2006


Ciba Specialty Chemicals has submitted a master file to the Centre for Devices and Radiological Health of the US Food and Drug Administration (FDA) for its silver-based antimicrobials for medical device applications.

The master file can be immediately cross-referenced by marketers and developers of devices containing the novel silver-based technology to support regulatory approvals. The data set contained in the master file includes anticipated device applications, chemistry, and toxicology data along with detailed descriptions of manufacturing, labelling, packaging, and distribution processes and practices and the associated quality controls that are in place. Ciba plans to submit additional master files for related products to the FDA in the future.

HyGentic 4000, a form of elemental silver with distinctive physical properties, was developed by Bio-Gate AG and is distributed globally by Ciba. It is particularly suitable for implanted or inserted medical devices where antimicrobial solutions are increasingly in demand.

See more

You may also like

Analysis

The case for a facility monitoring system

Read more
In regulated manufacturing, monitoring environmental conditions and critical equipment is essential to protect product quality, yield, and patient safety. Facilities often use a Facility Monitoring System (FMS) to track factors like airborne particles, temperature, and humidity. Beyond regulatory compliance, FMS delivers real business value through reduced waste, improved yield, higher quality, and greater profitability

Trending Articles

  1. AdvanceTEC drives cleanroom innovation & growth with acquisition by Equans Leveraging scale, global reach, technology, prefabrication & modularisation
  2. Medicinal cannabis production with GMP-compliant cleanroom solutions Controlled environments are supporting quality, safety and regulatory compliance in cannabis manufacturing
  3. You need to be a subscriber to read this article.
    Click here to find out more.
    President Trump signs order for “regulatory relief” for domestic pharmaceutical manufacturers The US President has signed an executive order to direct the FDA to review current regulatory procedures, such as by reducing inspection frequency
  4. Pharmaceutical carbon reduction expert EECO2 achieves B Corp status A relatively unique certification in the cleanroom design industry, EECO2 has been determined to meet the necessary high standards of social and environmental performance, transparency, and accountability for B Corporation status
  5. You need to be a subscriber to read this article.
    Click here to find out more.
    Integrating “high-voltage leak detection” into automated visual inspection Leoni Ransmann and Jan Sende from Syntegon Technology talk about visual inspection of product containers like ampoules, which has been the industry standard for decades, and compare it to modern methods being emphasised in documents like the new EU GMP Annex 1

Upcoming event

Cleanzone Middle East

September 18-19 2025 | Conference | Conrad Dubai, United Arab Emirates See all

You may also like

Analysis

The case for a facility monitoring system

In regulated manufacturing, monitoring environmental conditions and critical equipment is essential to protect product quality, yield, and patient safety. Facilities often use a Facility Monitoring System (FMS) to track factors like airborne particles, temperature, and humidity. Beyond regulatory compliance, FMS delivers real business value through reduced waste, improved yield, higher quality, and greater profitability
Pharmaceutical

300 hours of performance with APSPG-Max

NewAge Industries, Inc., parent company of the AdvantaPure™ line of tubing, hose and quality accessories for the high-purity market, announces the launch of its’ newest line of tubing, AdvantaSil APSPG-Max silicone pump tubing
Design & Build

Kemtile to showcase single source flooring solutions at PPMA 2025

Kemtile is using PPMA 2025 to engage prospective customers on the benefits of coming to an internationally-backed industrial flooring and drainage business with a single source approach to flooring projects across the process and packaging industry
Pharmaceutical

Steriline at CPHI 2025

Flexibility, robotics and customisation for a zero loss approach
Design & Build

AdvanceTEC drives cleanroom innovation & growth with acquisition by Equans

Leveraging scale, global reach, technology, prefabrication & modularisation
Pharmaceutical

Steriline at Pharma Pro&Pack Expo 2025

With its own branch already established in India, Steriline confirms the importance of the Indian and of Asian markets in general for its growth and development
Design & Build

Preserve and protect your cleanroom with a Guardtech Group Cleanroom Service Plan

Suffolk-based construction experts offering elite packages to ensure all service, maintenance and decontamination needs are taken care of
Subscribe now