Feb 22, 2024

Understanding the Essentials of EU GMP Annex 1 Section 9

Feb 22, 2024

EU GMP Annex 1 Merges with Pharma 4.0

Feb 7, 2024

The Future of Cleanroom Air Filtration: Advanced Systems for Enhanced Compliance

In the world of cleanrooms, where the highest standards of cleanliness and contamination control are paramount, air filtration systems play a pivotal role. The evolution of these systems, especially with the integration of advanced features, has significantly improved compliance with stringent industry standards. In this blog, we delve into the intricacies of these advanced air […]

Dec 19, 2023

EU GMP Annex 1 Continuous Viable Monitoring

Dec 13, 2023

EU GMP Annex 1:2022 and Microbial Monitoring for Viable Particulates

The 2022 update of the EU GMP Annex 1 has placed significant emphasis on the concept of continuous environmental monitoring (EM), highlighting it as a critical component in reducing the risk of contamination during the manufacture of sterile products.  This shift towards continuous EM requires manufacturers to adopt specific techniques and align their monitoring programs […]

Nov 2, 2023

USP 797 AND ITS IMPLEMENTATION IN ASEPTIC COMPOUNDING ENVIRONMENTS

Oct 25, 2023

Understanding ISO TR 14644-21

Oct 18, 2023

Simplifying USP 788

Compliance with USP 788 standards doesn’t have to be a complex and laborious process. Recent advancements in liquid sampling technology have made achieving USP 788 compliance both simple and effective. Liquid sampling plays a crucial role in contamination control strategies, ensuring that particulate contaminants are kept out of injectable pharmaceutical products and, ultimately, the bodies of end-users. […]

Sep 13, 2023

The Vital Role of Contamination Control Strategy and Environmental Monitoring

In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are paramount, Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products 2022 stands as a crucial document. One of its core components, the Contamination Control Strategy (CCS), plays a pivotal role in ensuring the production […]

Jun 8, 2023

OVERVIEW OF EU GMP ANNEX 1:2022

Mar 30, 2023

How To Prepare A Contamination Control Strategy Document as Per New GMP Annex 1

Mar 22, 2023

How To Develop and Document a Contamination Control Strategy

Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where you plan how to avoid contamination, what to do in the event there is a breach, and prove that you have done your homework.  For too many years, a CCS has been an afterthought. The cleanroom was developed, protocols put in […]

Mar 8, 2023

Risk Management and GMP Annex 1: Strategies for Minimizing Contamination

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, released a new update in 2022. At the time of publishing, we have not yet seen updates in the United States, but should expect to see similar guidelines published […]

Dec 21, 2022

EN ISO 14698-1 & -2:2003 vs EN 17141:2020

In 2020, a vote found EN ISO 14698 no longer suitable for use in Europe, and, thus, it was replaced by EN 17141. Now, there is a push to accept EN 17141 as the international standard, as it is significantly more up to date and applicable than EN ISO 14698.  EN ISO 14698 was last […]

Dec 14, 2022

Getting From EN ISO 14698 to EN 17141

After 17 years of no revisions, a formal vote in 2019 replaced EN ISO 14698 with EN 17141 in Europe. Shortly after, confusion ensued. While CEN/TC243 (the technical committee in CEN) had found EN ISO 14698 obsolete and replaced it with a new guidance (under a new number, to avoid confusion), old versions still existed […]

Nov 23, 2022

Microbiology & Bio contamination Control in Cleanrooms From EN ISO 14698 to a new EN 17141

Nov 16, 2022

What Is EN 17141?

EN 17141 Cleanrooms and controlled environments – Biocontamination control is a relatively new European standard, introduced in 2020, that establishes and demonstrates best practices to control airborne and surface microbiological contamination in controlled environments, such as cleanrooms. This standard applies specifically to European cleanrooms in the pharmaceutical and biopharmaceutical, hospital, and food industries, as identified […]

Nov 7, 2022

Overview of GMP Annex 1 and its impact on Environmental Monitoring

Oct 26, 2022

GMP Annex 1 2022 Update Breakdown: Part 2

In 2017, GMP released a draft update to Annex 1, which received a lot of feedback. Now, GMP has released a finalized version of the updated Annex 1, which addresses many of the concerns and questions raised about the draft version. The largest changes and shifts in this document are found in the increased focus […]

GMP Annex
Oct 19, 2022

GMP Annex 1 2022 Update Breakdown: Part 1

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft left many people operating in the pharmaceutical industry wondering at some of the proposed changes to the regulations that […]

Cleanroom gas sampling basics instructions
Oct 5, 2022

Basics Of ISO 8573

If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines and regulations for your cleanroom, specifically ISO 8573-1:2010. This set of guidelines is maintained and governed by the International Organization for Standardization (ISO), an international, non-governmental organization dedicated to creating worldwide standards for a variety of industries. ISO standards […]

Sep 22, 2022

GAMP5’s Impact On Developing Monitoring Systems

Good Automated Manufacturing Practices (GAMP). GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. ISPE is the world’s largest not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire […]

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Data_Integrity_Blog
Sep 21, 2022

The Basics Of 21CFR11 And GAMP5 For Data Integrity In A Cleanroom

If you know us, then you know that clean air and water is our passion in life. But what happens when you cannot prove to the regulatory authorities that your air and water is clean? Cleanrooms and monitoring systems generate a lot of data. In an 8 hour shift, as many as 5,000 individual count […]

ISO 14644 Certified
Jul 20, 2022

What Is ISO 14644 And Why Does It Matter For Your Cleanroom?

ISO 14644 is a standard for cleanrooms that was developed by the International Standards for Organization (ISO). The ISO has been in existence since 1947, after 65 delegates from 25 different countries met to discuss its future the previous year. They saw the need for a non-governmental body whose sole job it was to determine […]

Jul 13, 2022

Basics On Minimizing Contamination Risk In Your Cleanroom

What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and physical threats to the end user. It is something that should be avoided wherever possible.  To minimize contamination risk in your cleanroom, you first need to understand what contamination control […]

Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

Jun 29, 2022

Questions to Ask About The Application of 21 CFR Part 11 In Your Operations

The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the requirements of this FDA code in order toenable Data Integrity and Data Traceability as well as the electronic signatures that verify the dataas original, valid, and accurate

Jun 16, 2022

21 CFR part 11 Overview

21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 CFR Part 11 has 10 chapters over 3 subsections. These subsections are General Provisions, Electronic Records, and Electronic Signatures.

Apr 28, 2022

What is GAMP and why is it so important in Cleanroom Manufacturing?

Feb 23, 2022

Understanding and Applying USP 788 Best Practices

Feb 23, 2022

Water For injection Liquid Monitoring for Pharmaceuticals

Water is one of the major utilities used by the pharmaceutical industry. Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resources to the development and maintenance of water purification […]

Feb 2, 2022

USP 788 Testing for Particles in Injectable Products

We are all too well aware of the adverse effects of particulate matter contamination within parenteral injectable pharmaceutical products and the consequences for patient safety. Here, particulate matter refers to the small, sub visible particles. The United States Pharmacopoeia, USP <788> provides two tests for detecting such particulates: light obscuration and microscopic assay. Both are […]

Sep 27, 2021

Active Air Sampling Technology & ISO 14698

Sep 8, 2021

ISO 14644-1:2015 and ISO 14644:2-2015 Review

cleanroom tech
Jul 17, 2021

The Guide to Creating A GMP Training Program

Good Manufacturing Practices (GMPs – sometimes referred to as Current Good Manufacturing Practices or CGMPs) are federal regulations set by the FDA to cover how pharmaceuticals and food products are manufactured. They are guidelines taken for granted by many consumers – they assume what they put in their body will have been safely produced – but […]

Jun 23, 2021

EN17141 “Bio contamination Control” and Microbiology in Cleanrooms & Controlled Environments

Jun 16, 2021

Let’s Prepare an ISO 14644-1 and GMP Annex 1 Cleanroom Classification Report Together

May 13, 2021

GMP Annex 1 2020 Draft: Effects on cleanroom classification and monitoring

Mar 17, 2021

How to Prepare a Risk Based Cleanroom Monitoring Plan as per ISO 14644-2:2015

Feb 5, 2021

ISO 14644-3:2019 Cleanrooms and Associated Controlled Environments-Test Methods

Jan 22, 2021

GMP Annex1 2020 Draft and its Effect on Cleanroom Classification and Monitoring

Aug 26, 2020

Prevent Failure by Designing Your Cleanroom Monitoring System to Meet cGMP

Jul 22, 2020

Performance Qualification of Environmental Monitoring Systems

Jul 7, 2020

Annex 1 2020 Draft and Cleanroom Monitoring

Jun 26, 2020

Annex 1 2020 Draft and Cleanroom Classification

Jan 24, 2020

An Introduction to EU GMP (European Union Good Manufacturing Practices) Annex 1 – Part 2 of 2

Jan 22, 2020

An Introduction to EU GMP ( European Union Good Manufacturing Practices) Part 1 of 2

Oct 15, 2019

ISO 14644 Family Overview

Jul 17, 2019

ISO 14644:2-2015 Creating, Implementing, and Maintaining a Monitoring Plan

Jun 8, 2019

Understanding the basics of ISO 14698-1 / Biological Contamination

May 25, 2019

Brief introductory overview of ISO 14644-2 / Part 3 of 3 – Sampling Locations and Considerations

May 19, 2019

Brief introductory overview of ISO 14644-2 / Part 2 of 3 – Cleanroom Particle Sampling Methods

May 8, 2019

Brief introductory overview of ISO 14644-2 / Part 1 of 3 – Cleanroom Monitoring

May 4, 2019

Introduction to ISO 14644-1 Room Classifications