Contamination Control for Aseptic Manufacturing with the Pharmaceutical Industry: Recent Episodes
Particle Measuring Systems
Conversations focused on contamination monitoring and control around best practices and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
In Season 2, Episode 2 of the Marc and Mark Contamination Control Podcast, Marc Machauer and Mark Hallworth, particle monitoring experts at Particle Measuring Systems, discuss the new release of ISO 14644-21: 2023 Airborne Particle Sampling Technique. Mark Hallworth served on the ISO task force to rewrite this standard. They discuss behind-the-scenes stories from the writing of the new standard, including topics such as tubing length, isokinetic sampling, and best practices.
What is quality data from contamination contol sources and how do you interpret it within the pharmaceutical manufacturing environmental monitoring? Long-term industry experts Marc Machauer and Mark Hallworth discuss the importance of collecting the right contamination control data and understanding what it means. PMS offers risk analysis through its advisory team. Learn more here https://www.pmeasuring.com/advisory-services/
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Part 5 of this Limited Series on the Journey to Data Quality is hosted by Daniele Pandolfi, PLM Data Management. Daniele discusses what you will now be able to achieve with all the data you've thoughtfully and methodically collected.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Part 4 of this Limited Series on the Journey to Data Quality is hosted by Daniele Pandolfi, PLM Data Management. Daniele discusses how thinking ahead to how and where to collect data is an important part of process design.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Part 3 of this Limited Series on the Journey to Data Quality is hosted by Daniele Pandolfi, PLM Data Management. Daniele discusses how data quality pertains to cleanroom Classification and Qualification and how that data can help you keep your processes in complete control.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Part 2 of this Limited Series on the Journey to Data Quality Daniele is hosted by Daniele Pandolfi, PLM Data Management. Daniele discusses how to design an environmental monitoring plan that gives you the power to effectively control your processes using data outputs.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Welcome to this new Limited Series podcast on the Data Quality Journey in Pharma Manufacturing from the experts at Particle Measuring Systems.
Hosted by Daniele Pandolfi, PLM Data Management, this introductory episode describes what the overall journey to Data Quality looks like, and what will be covered in the following episodes.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Welcome to Season 2 of the Marc and Mark Podcast!
Hosted by Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business Manager, and Mark Hallworth, Senior Global GMP Scientist.
In Season 2 Episode 1 of this podcast, Marc and Mark discuss the topic of performing a contamination control Risk Assessment, as required by Annex 1: 2022, on fill lines with manual (vs. solely mechanical or robotic) processes. These manual processes are frequently found in ATMP manufacturing, and pharmaceutical compounding; and are often performed in laminar flow hoods with limited space.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
In Part 10 of this Limited Series from Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the topic of performing a retroactive Risk Assessment on existing fill lines as required by the recent release of EU GMP Annex 1.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
In Part 11 of this Limited Series from Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the unique challenges manual fill processes, typically performed under laminar flow, present to performing risk assessments. A Risk Assessment is an important part of a good contamination control strategy, and is required by the recent release of EU GMP Annex 1.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
Particle Measuring Systems, a Spectris company, has a goal of Net Zero (2030 for Scope 1 and 2; 2040 for Scope 3). The plan has been validated by the Science Based Targets Initiative. In this interview, Rebecca Dunn (Head of Sustainability for Spectris) talks about the progress and the reality of hitting our goals
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
In Part 9 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the unique environmental monitoring issues encountered when manufacturing products with high toxicity profiles.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
In Part 8 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the environmental classification, management, and effective monitoring of Grade B & C areas surrounding Isolator and RABS systems.
Without measurement there is no control
Do you have questions about today's topic?Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.
In Part 7 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss nonviable particle counter sample tubing concerns raised by the most recent EU GMP Annex 1 release. Their conversation includes how particles act in tubing, optimum tubing length, acceptable risk, and other variables contributing to obtaining effective and actionable particle counts in aseptic manufacturing.
EU GMP Annex 1 has been released after much anticipation, and new revisions tend to cause confusion. PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions.
In Part 6 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss environmental monitoring systems on aseptic fill lines and best practices for their installation to ensure accurate viable and nonviable particle monitoring. Their discussion includes considerations around vacuum systems, sample tubing, and ensuring monitoring flexibility.
In Part 5 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the environmental monitoring data that is generated by Facility Monitoring Systems and how to collect, evaluate, and use that data to make informed decisions. Their discussion includes how system-based data from individual sensors is collected and how to translate that data into meaningful and actionable information about a clean area.
In Part 4 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the path of nonviable/microbial particles inside a Pharmaceutical aseptic fill machine. Their discussion includes active air monitoring vs. settle plates in isolator environments, and best practices in sampling for contamination control.
In Part 3 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the path of nonviable particles inside a fill machine/isolator and best practices in sampling for contamination control.
In this interview, Dwight Beal, Product Line Manager and Industry liquid contamination monitoring expert, talks about Particle Measuring Systems newly released Ultra DI 20 UPW particle counter, which measures particles in liquids down to 20 nm.
In Part 2 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss pharmaceutical manufacturing contamination control strategy and risk assessment.
In Part 1 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the history and developments in cleanroom Environmental Monitoring over the past 25 years.
In this interview, Blu Buquoy, Marketing Specialist and Paul Hartigan, Global Product Line Manager , sit down to discuss and compare the new IsoAir Pro E and IsoAir Pro Plus, Aerosol Particle Sensors that complete the Pro Product line at Particle Measuring Systems.
In this interview, Blu Buquoy (Marketing Specialist) and Giulia Artalli (Product Line Manager at Particle Measuring Systems), sit down to discuss what makes the Biocapt Single Use the only solution for reliable and continuous active microbial monitoring.
As part of Particle Measuring Systems' 50th Anniversary celebration, Leah Chandler talks to Paul Kelly, third President of PMS to learn more about the fifteen years he led the company.
In this interview, Blu Buquoy (Marketing Specialist) and Paul Hartigan, Lasair Pro Global Product Line Manager at Particle Measuring Systems (PMS), sit down to discuss what makes the new Lasair Pro airborne particle counter truly a next generation instrument. Highlights include:
- Room Certification Wizard, per ISO 14644-1.
- Use the Lasair Pro as part of a portable or remote monitoring plan, per ISO 14644-2.
- How the Lasair Pro meets 21 CR Part 11 data integrity
- Instrument security and Audit Trail functionality that tracks all operations that occur while using the instrument.
- The Lasair Pro was designed with the future in mind (ex: EU GMP Annex 1) and is able to accommodate anticipated advances in the industry and technology as they occur.
Learn more about the Lasair Pro particle counter.
As Particle Measuring Systems celebrates 50 years in business, John Mitchell, President PMS, talks about accomplishments and next steps.
Learn about Particle Measuring Systems' Roadmap to Net Zero, progress, priorities, and Earth Month 2022 plans.
In this video interview, the team from AUSTAR UK discuss why and how they worked with Particle Measuring Systems’ (PMS) exclusive UK distributor, EMS Particle Solutions, to provide an AUSTAR Sterility Test Isolator customer with a complete viable and non viable contamination monitoring solution using PMS instrumentation and equipment.
Together with EMS Support and expertise and PMS world-class products, AUSTAR used the following solutions to provide complete contamination control for their customer:
- MiniCapt Mobile Active Air Microbial Sampler for comprehensive microbial sampling with secure data management and reduced operator error.
- Combined with the: BioCapt Viable Impactor, with a unique radial slit design for easy false positive identification resulting in a fully validated microbial monitoring system.
For non viable particle monitoring:
- Lasair Airborne Particle Counter is a complete non viable contamination control solution including clean area monitoring (portable and remote) while meeting global requirements for data integrity.
Austar contamination control solution
AUSTAR Group is a leading technology-based pharmaceutical engineering solution provider with comprehensive knowledge and experience in life-science process technology, applications, industry regulatory rules and practices. AUSTAR is able to help clients address issues in quality, compliance and operations excellence. They are dedicated to providing equipment-engineering-service-consumables turnkey solutions that promote industry advancement and create value.
EMS Particle Solutions is dedicated to customers, technology innovation, & continued professional education. This, and more, solidifies EMS’ position as industry leaders in contamination control solutions for controlled environments in the UK and Ireland.
Daniele Pandolfi, product line manager at Particle Measuring Systems, talks to Ugo Omeronye, Advisory Services, regarding Cleanroom / Facility Monitoring Systems (FMS) vs. Building Management Systems.
The new EU GMP Annex 1 draft, Rev 12 specifies the requirements of a pharmaceutical risk assessment to set appropriate microbiological plate conditions. This blog discusses this requirements to use a risk assessment, and then provides an interpretation on how to apply it and use it in different stages of the manufacturing process.
There are three main concepts regarding this:
- “Quality Risk Management” applies to all of Annex 1 and is the underlying concept for understanding and interpreting Annex 1.
- A relevant Pharmaceutical Risk Assessment is expected for each area.
- Companies are expected to implement a Quality Assurance system to fulfill the quality objectives associated with various areas of interest
Section 9 of Annex 1 says that a Risk Assessment should be used to establish a comprehensive environmental monitoring program, including:
- sampling locations
- sampling frequency
- method used
- incubation conditions
A pharmaceutical Risk Assessment should be based on knowledge of:
- historical monitoring data
- monitoring data obtained during qualification
- knowledge of typical microbial flora isolated from the environment
The result of the Risk Assessment is to establish the most appropriate incubation conditions to identify all potential microorganisms associated with an environment. That is, the goal is to demonstrate that your methods have considered all risks for maximum recovery of microorganisms. This is particularly important in Grade A and B Cleanrooms where the counts are generally very low, and the environmental conditions do not favor microbiological detection.
Next steps
- Establish the most appropriate incubation conditions to identify all potential microorganisms associated with your environment
- Take information from USP and EU Pharmacopeia
- Risk Assessment: Evaluate the environment and process/product
- Risk Assessment: Review data regularly to confirm the effectiveness of the conditions
A Pharmaceutical Risk Assessment should be holistic and evaluate the characteristics of the process, products, facilities and environmental conditions that favor the growth of:
- anaerobic microorganisms
- slow-growing microorganisms
- yeasts and molds
There are differences in performing a Risk Assessment in existing or new departments. For example, in existing departments, there is historical data would should be considered. In a new department with no historical information, you must define the incubation condition based on a scientific-based approach.
Ready to get started?!
Particle Measuring Systems has a contamination control advisory team that can provide you with sterility assurance audits to prepare you for the review of the regulatory agencies or to identify the areas where to improve. Contact us to learn more.
An interview with Mark Hallworth by podcast host Ugo Omeronye.
Environmental Risk Assessment series focused on PQ Systems and Tools.
Severity, probability, and detectability of contamination.
Environmental monitoring, contamination control for aseptic pharmaceutical manufacturers.
Particle counting, microbial monitoring, and data for effective cleanroom monitoring to meet regulations including EU GMP Annex 1 and ISO 14644.
Learn more: https://www.pmeasuring.com/performance-optimization/
Learn about the currently drafted sections in Annex 1, draft 12 that deal with viable monitoring requirements and future expectations.