Validation Support

Bio Clean Room (BCR) Technology

Taikisha's Technology

What is Biological Clean Room (BCR) technology?

Comprehensive construction technology for clean room relating to pharmaceutical manufacturing such as decontamination system and validation support. e.g. room pressure control system for stable manufacturing environments to comply with each country's GMP, reliable contamination barrier to shut up toxic substances.

Can provide solutions to these problems

  • Want to lift productivity
  • Want to improve labor environments and achieve automation

Overview

Taikisha supports validation measurement tasks for air conditioning equipment. Alternation of the measured data is prevented from tampering with the measurement data, while greatly reducing time for summarizing data or writing reports.

Features

  • Support of validation measurement tasks

    Filter leak tests
    It can scan the filter surcace according to the voice guidance, allowing it to measure at a set speed.
    Wind speed distribution tests and cycle count tests
    They can acquire memory data of an anemometer, shortening time for maeasurement.
  • Automatic yes-no decision and reporting

    Automatic yes-no decision and reporting to allow confimation of the results of measurement onscreen reduces load for form aggregation, and prevent misjudgement or losing measured data.

  • Support of security/GAMP5 (including Part 11)

    Computerized system validation (CSV) compliant with GAMP 5 is implemented and CFR Part 11 is supported. (E-signatures, tamper prevention, audit tracking, etc.) User management independently is allowed by OS account. Operation is allowed by authorized user only, so data is prevented from unexpected accidents or loss.

Validation Ace-M
Sample

Specifications

Operable measuring instruments

Primary side particle counter

RION Co., Ltd. KC-01E

Secondary side particle counter

Hach Ultra Analytics
  • A2400 series
  • A3400 series

Anemometer

KANOMAX JAPAN, INC Model65 series

Compatible OS

  • Windows 7
  • Windows XP