GMPc Vietnam JSC
  • About Us  
    • Summary information
    • Key Personnel
  • Services  
    • WHO GMP Pharmaceutical facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory  
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing  
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center  
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses  
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities  
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training  
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation  
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce  
      • Announcement of Imported Cosmetic
    • Dairy Factory  
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact

    FAQS

  1. Home
  2. FAQS
  3. MATERIAL

List of FAQS

  • GMP GENERAL QUESTION
  • FACILITY AND EQUIPMENT
  • PERSONNEL
  • MATERIAL
  • PRODUCTION AND PROCESS CONTROL
  • HOLDING AND DISTRIBUTION
  • LABORATORY CONTROL
  • RECORD AND REPORT
  • AUDIT
  • OTHER Q&A
How should the integrity of sterilising filters be verified?

06/07/2021 | 2650

Similar question:

Reply:

The filter sterilisation process may be physically stressful for the filter. For example, high temperatures during the process may cause the filter to distort, potentially leading to fluid pathways that allow the passage of particles greater than 0.2 μm in size. The performance of a filter can improve with use, as particles begin to block individual pathways and remove larger pathways that smaller particles could successfully navigate. For these reasons, filters should be tested both before use but after sterilisation and again after use.
Furthermore, testing should be performed in situ in order to verify the integrity of the filter complete with its housing.

Related Q&A

How Materials is required follow WHO GMP? See more How Materials is required follow WHO... See more
Raw material for API production: are on-site audits required for all suppliers? See more Raw material for API production: are... See more
A batch of an API has been released before all testing and final approval was completed. How do... See more A batch of an API has... See more
How are APIs covered under the MRA? Do APIs non-MRA states have to be retested? See more How are APIs covered under the... See more
Does the manufacture and purchase of raw materials represent an activity governed by Chapter 7 of the EU... See more Does the manufacture and purchase of... See more
What are the sampling requirements for sterility testing when a finished product batch of terminally sterilized medicinal product... See more What are the sampling requirements for... See more
What are the key changes in the 2008 revision of annex 1 of the EU GMP? See more What are the key changes in... See more
The new revision to the annex includes a number of revised requirements. What steps are being taken by... See more The new revision to the annex... See more
For an aseptically produced product, where should bioburden monitoring take place? See more For an aseptically produced product, where... See more
What is the maximum acceptable bioburden level? See more What is the maximum acceptable bioburden... See more
123>
  • GMPc Vietnam JSC
  • Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Business location : No. 32, Vi Cam 5 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Tel: 0243.787.2242 | CEO hotline: 0982.866.668
  • Email: contact@gmp.com.vn
  • Representative Office: 156/1/1, Cong Hoa Street - Ward 12 - Tan Binh District - Ho Chi Minh City
  • Tel: 0283.811.7383 
  • Quick link
  • About Us
  • Services
  • Project
  • GMP-Handbook
  • Video
  • Consulting for cosmetic facility
  • Consulting for health supplement facility
  • Consulting for GSP warehouse
  • Fanpage
Facebook

Copyright © 2020 GMPc. All rights reserved.

  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
Hotline: 0982.866.668
Nhắn tin Facebook Zalo: 0982.866.668