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  • Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability. Although  "equipment cleaning" is part of  current Good Manufacturing Practice requirements the term
    "cleaning validation" was not popular until late 1980s. The need for a systematic approach to proving the effectiveness of  all the cleaning procedures was  achieved in 1993 with a revised Food  and Drug Administration Inspection  Guide on Cleaning Validation.
  • The objective of the cleaning
    validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation
    products, preservatives, excipients and/or cleaning agents so that the analytical monitoring may be  reduced to a minimum in the routine  phase. In addition one needs to ensure  there is no risk associated with cross contamination of active
  • High risk products, such as
    penicillin's, are a major concern in the cleaning validation field. Sensitive sampling methods require development and must be applicable to each specific piece of equipment used. Due to the possibility of  inter-product contamination, highly sensitive analytical methods such as LiquidChromatography are required for trace level  analysis.
  • Pharmaceutical plants must have visually clean equipment to operate according to good manufacturing practices. Formulators must visually inspect manufacturing equipment for cleanliness before formulation work
    begins (1). Manufacturers establish and perform visible cleanliness and analytical methods to ensure regulatory compliance. An analyst conducts a visual inspection and confirms visible cleanliness before taking swab samples for chemical analysis (2). The formulator of the subsequent batch conducts a visual inspection before manufacturing work begins. A correlation between available analytical data and visible
    cleanliness of manufacturing
    equipment over an extended period of time can expand the practice of performing visual inspections in lieu of swab sampling
  • Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis) and TOC. HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances. TOC is classified as a non-specific method and is ideal for detecting all carbon-containing compounds,
    including active species, excipients, and cleaning agent.
General Information
  • Introduction to Cleaning Validation
  • Cleaning Validation, how clean is clean?
  • Process Validation Support
  • Cleaning Validation
  • An Overview Of Pharmaceutical
  • Cleaning Validation
  • Cleaning Procedures
  • Pat For Pharmaceutical
  • Pharmaceutical Applications
  • Simplifying pharmaceutical cleaning validation
  • Pharmaceutical Applications for TOC

Equipments Needed

  • Medical Ultrasonic Cleaners
  • Welcome to Tooltek Engineering
  • Ultrasonic Cleaners
  • Aqueous cleaning and disinfection
  • Sanitary Spray Balls for Critical Cleaning
  • Our Standard Products
  • Automatic Ultrasonic Cleaning Machine
  • Pharmaceutical Equipment Ultrasonic Cleaners
Examples & Calculation
  • Pharmaceutical Cleaning Validation
  • Total Organic Carbon Analysis
  • A Roadmap to an Effective Cleaning Program
  • GMP/Validation
  • Validation Services
  • Advanced Technology
  • Analytical Method Development
  • Direct Swabbing and Surface Recovery
  • IMS for Cleaning Verification
  • In situ spectroscopic cleaning validation
  • Ion trap mobility spectrometry
  • Smiths Detection
  • A High Throughput
  • Process Technology
  • Cleaning Validation Technologies


  • Cleaning Validation Guidelines
  • Guide To Inspections Validation 
  • Health Products
  • Guidance on aspects
  • Proposed Validation Standard
  • Risk-Management Assessment
  • Method For the Assessment
  • Method Of Removing
  • Cleaning Compositions
  • Use Of Surfactants
  • Application of Visible
  • Pharmaceutical Industry Solutions
  • Method Development of Swab Sampling
  • Measurement & Validation
  • Validation: An Essentiality In The Pharmacy
  • Validation Of Cleaning Methods
  • Requirements For Process
  • Cleaning Validation in Active  pharmaceutical
  • Effective Cleaning and Sanitizing
  • Evaluation Of Cleaning
  • Risk-Based Cleaning
  • Global Programme For Vaccines
  • Continuous Monitoring
  • Analytical Services Laboratory
  • Development of an In Situ Spectroscopic Method

Detergents & Surfactants

  • Low-Foaming Powdered Detergent
  • Selecting the Right detergent
  • Aqueous Cleaning
  • Ionscan tops Hplc
  • Liqui-Nox
  • Surfactant-Enhanced Aquifer Remediation
  • Shimadzu
  • Superior Performance


  • Total Organic Carbon Analysis
  • Cleanliness & Contamination
  • IonScan-LS IMS
  • Mid Atlantic Region


  • A Brief Introduction to API / HAPI Plant Design
  • Layton Technologies offers the greatest versatility
  • Teledyne
  • Testing a New Chromatography Column
    for Cleaning Effectiveness

Company Profile

  • Our philosophy, guidelines and goals
  • Contamination Control
  • Quality Analytical Services
  • Gibraltar Company Profile


  • Jm hyde
  • Who We Are - Those We Serve -
    Our Facility
  • Cleaning Validation Technologies
  • Cmac consultancy
  • Cleaning Validation Acceptance
  • pharm
  • Taratec
  • Soli Pharma Solutions


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Primary Information Services
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Ullagaram, Chennai - 600091, India.
 Phone: 91 44 22421080 
Email :
Mobile numbers:9940043898, 9444008898  Fax : 91 44 22423753