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Enriched Life Sciences and Technology is a pioneering life science and technology company dedicated to advancing cleaning validation processes through innovative software solutions. Leveraging the American Society for Testing and Materials (ASTM) International Standard Guidesfor cleaning process development and validation, our solutions empower organizations to adopt science-based, risk-based, and statistics-based approaches to cleaning process development and validation.

Our mission is to revolutionize cleaning validation by delivering innovative software and expert-driven solutions that streamline and optimize cleaning validation workflows, ensuring alignment with regulatory standards and best practices.

Through collaboration with a renowned Center for Pharmaceutical Cleaning Innovation (CPCI); a not-for-profit research organization created by Andrew Walsh, we merge advanced research and expert education to offer a comprehensive suite of solutions for the Pharmaceutical, Biotech, Nutraceuticals, Cosmetics, and Medical Device industries.
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Through collaboration with the Center for Pharmaceutical Cleaning Innovation (CPCI™) , we are developing FREE and FEE-Based software tools to support pharmaceutical, biologics, nutraceutical, cosmetic and medical device companies that are implementing the science, risk and statistics-based cleaning validation per the ASTM E3106 Standard Guide "Science-Based and Risk-Based Cleaning Process Development and Validation".
CPCI™ HBEL Calculator

This CPCI™ HBEL calculator was developed by CPCI™ from the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs) to be used by Qualified Experts. The purpose of this HBEL calculator to provide an easy-to-use tool to help companies implement the guidance found in E3219.

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CPCI™ Swab/Rinse Limit Calculator

This calculator generates swab/rinse limits based on ASTM E3418 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices.


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HBEL (ADE/PDE) Derived Toxicity Scale Tool

This HBEL (ADE/PDE) Derived Toxicity Scale Tool is developed to apply scientific and risk-based approaches to cleaning validation outlined in ASTM E3106 – “Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation”.


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Process Capability (Cpu) Derived Scale Tool

This CPCI™ HBEL calculator was developed by CPCI™ from the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs) to be used by Qualified Experts. The purpose of this HBEL calculator to provide an easy-to-use tool to help companies implement the guidance found in E3219.

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Detectability Scale (TOC) Tool

This calculator generates swab/rinse limits based on ASTM E3418 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices.


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Detectability Scale (Visual Inspection) Tool

This HBEL (ADE/PDE) Derived Toxicity Scale Tool is developed to apply scientific and risk-based approaches to cleaning validation outlined in ASTM E3106 – “Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation”.


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Cleaning Risk Assessment Dashboard

This HBEL (ADE/PDE) Derived Toxicity Scale Tool is developed to apply scientific and risk-based approaches to cleaning validation outlined in ASTM E3106 – “Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation”.


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Most flexible pricing

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CPCI™ is a renowned not-for-profit research organization created by Andrew Walsh.

CPCI™ Vision is to be the premier source of research, education and consulting for Science- Risk- and Statistics-based Cleaning Process Development and Cleaning Validation for Pharmaceutical, Biotech, Cosmetics and Medical Device companies.

In collaboration with CPCI™, we merge advanced research and expert education to offer a comprehensive suite of software solutions for the Pharmaceutical, Biotech, Nutraceuticals, Cosmetics, and Medical Device industries. Through this collaboration we are developing both FREE and FEE- Based software tools to support companies that are implementing the science, risk and statistics-based cleaning validation per the  ASTM E3106 Standard Guide "Science-Based and Risk-Based Cleaning Process Development and Validation" . To learn more about CPCI™ click the link below:

https://www.centerforpharmaceuticalcleaninginnovation.org/ logo

Let’s Innovate Together

Contact Us Today

Ready to transform your cleaning validation processes? Reach out to [Company Name] and learn how we can help you achieve the highest standards of drug safety and quality.

Email: info@[companydomain].com

Phone: [Insert Phone Number]

Address: [Insert Address]

Cleaning Validation Publications and ASTM Standards


To learn more about ASTM International's Standards click the link below:

https://www.astm.org/

  1. ASTM E3106 "Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation" ( https://www.astm.org/e3106-22.html)
  2. ASTM E3109  "Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)" ( https://www.astm.org/e3219-20.html )
  3. ASTM’s G121 “ Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents "  update to include pharmaceuticals and Medical Devices ( https://www.astm.org/g0121-18.html )
  4. ASTM  G122 “ Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes" update to include pharmaceuticals and Medical Devices ( https://www.astm.org/g0122-20.html )
  5. ASTM E3263 “ Standard Practice for Qualification for Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues" ( https://www.astm.org/e3263-22e01.html )
  6. ASTM E3418   "Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices" ( https://www.astm.org/e3418-23e01.html )

Title Year Published
Cleaning Validation for the 21st Century: Can Alternative Approaches to the PDE-ADE be Justified?
 Oct-15
Cleaning Validation for the 21 Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I
 Jul-11
Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs) - Part II
 Sep-11
Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
 Nov-13
Introduction to the New ASTM E3418 "Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices"
 Dec-23
Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
 Aug-22
Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs)
 Jul-20
Health-Based Exposure Limits: How Do The EMA's Q&As Compare With New And Forthcoming ASTM Standards?
 Nov-18
Are high potency active pharmaceutical ingredients (HPAPI) also high risks for cross-contamination?
 Dec-17
Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II
 Aug-16
Cleaning Limits-Why the 10-ppm Criterion Should Be Abandoned
 Jan-16
Deriving Health-Based Exposure Limits in the Pharmaceutical Industry
 Sep-15

Title Year Published
Cleaning Validation for the 21 Century: Overview of New ISPE Cleaning Guide
 Nov, 2011
Developing A Science-, Risk-, & Statistics-Based Approach To Cleaning Process Development & Validation
 Jan, 2017
Cleaning Process Development: Cleanability Testing And "Hardest-To-Clean" Pharmaceutical Products
 Jan, 2019
The Shirokizawa Matrix: Determining The Level Of Effort, Formality, & Documentation In Cleaning Validation
 Dec, 2019
Introduction To Science-And Risk-Based Cleaning Validation Using ASTM E3106 & E3219
 May, 2020
Introduction To The ASTM E3106 "Standard Guide To Science-Based And Risk-Based Cleaning Process Development and Validation"
 Jun, 2020
ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices
 Sep, 2020
Cleaning Process Development Selection Of Cleaning Agents For Pharmaceutical Products
 Nov, 2020
Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
 Dec, 2020
Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters Part of the Cleaning Validation For The 21st Century series
 Jun, 2023

Title Year Published
A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
 Feb-24
Measuring Risk In Cleaning : Cleaning FMEAs And The Cleaning Risk Dashboard
 Apr-18
A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities
 Aug-17
An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
 May-17
A Swab Limit-Derived Scale For Assessing The Detectability Of Total Organic Carbon Analysis
 Jan-18
An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
 Dec-17

Title Year Published
Validation Of Visual Inspection As An Analytical Method For Cleaning Validation
 Sep, 2017
Justification Qualification Of Visual Inspection For Cleaning Validation In A Low-Risk Multiproduct Facility
 Aug, 2018
Metadata Analysis - Justification and Qualification Of Visual Inspection For Cleaning Validation In A Low-Risk Multiproduct Facilit
 Aug, 2018
Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
 Sep, 2019
Introduction To ASTM E3263-20: Standard Practice For Quali cation Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
 Jan, 2021
Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues Part of the Cleaning Validation For The 21st Century Series
 Jan, 2023

Title Year Published
Calculating Process Capability Of Cleaning Processes With Completely Censored Data
 Oct-22
Calculating Process Capability Of Cleaning Processes With Partially Censored Data
 May-22
Calculating Process Capability Of Cleaning Processes: Analysis Of Total Organic Carbon (TOC) Data
 Jan-22
Calculating The Process Capabilities Of Cleaning Processes: A Primer
 Nov-21
The statistical evaluation of cleaning processes using process capability and its application to new product introduction
 May-18

Title Year Published
Microbial Aspects in Cleaning Validation
 Feb-11
Development of a Technique for Quantifying Protein Degradation
 Nov-16
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