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Biovis PSA2000 Automated Particle Size Analysis System (The 21 CFR Part 11 compliance module )

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Biovis PSA2000

Automated Particle Size Analysis System

Biovis PSA 2000 system designed to provide particle size and shape analysis with more than 70 measurements on size shape and color makes it a unique solution for R&D and QC applications in Pharmaceutical, Food processing, Paint , Ink Coating and many other applications. The 21 CFR Part 11 compliance module make it more preferred for the Manufacturing plants  working under USFDA guidelines. Report available on request,  is as per the regulatory requirements.

For R&D the non FDA version of the software can provide huge amount of data which can be mined to help find more information about the particulate matter based on its size and shape thereby improve the Drug delivery, Process Engineering , process development etc…

 

Biovis PSA2000 is an automated particle size analysis system for comprehensive investigation of different types of dry or wet particulate matter such as fibres, emulsions, crystals, powders, spray droplets, or suspensions, etc.

– Rapid automated analysis of thousands of individual particles

– Detect particles as small as 0.5 micron

– Compliance to FDA 21 CFR Part 11 standards

– Custom built analysis routines to handle specific sample types

– Detect and classify particle types on the basis of size, shape, color

– Professional Analysis Report generation

 

The Biovis PSA 2000 system with Biovis Particle Plus Ver 5.3 has the following features

  • Reports with D10, D50, D90 values.
  • Number and Volume distribution charts
  • Administrator  driven Login Policies.
  • Powerful macros/methods for automatic detection of different types of samples to achieve repeatable results with different users for same samples.
  • Micro Image documentation with Electronic Signature as per 21 CFR Part II compliance guidelines.
  • Complete audit trail to trace every action in each experiment.

Departments that can benefit from Biovis PSA 2000 system are

  • Process development/ Process Engineering
  • Quality Control ( Finished Material/ Inward Raw Material)
  • Performance of finished product ( Aspect ratio /roundness factor helps better design of final product)
  • Research and Development

For more information please go through the weblink http://www.expertvisionlabs.com/BiovisPSA.html

Naveen Hegde

Regards

Naveen Hegde

Expert Vision Labs

H202, Ranjit Studio,

DP Road, Dadar East,

Mumbai 400014

India.

Tel:+91 22 6637 2739 / +91 22 6637 1470

Mobile: +91 93240 51848

Fax : +91 22 6637 2739

Website : www.expertvisionlabs.com

email : nhegde@expertvisionlabs.com

Report available on request, or download  here is as per the regulatory requirements.
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