Environmental Monitoring, Keeping Your Rooms Ready

Environmental Monitoring, Keeping Your Rooms Ready

What is environmental monitoring?

Environmental monitoring describes the systems that allow pharmaceutical manufacturers to monitor and control the viable, non-viable, and environmental contamination in their cleanrooms. The environment of manufacturing and material/product storage is stored crucial. Specific regulations have to be met for your product to maintain its viability. When preparing your facilities’ production room and storage areas, environmental monitoring should be discussed. Environmental monitoring consists of temperature monitoring, particle counts, and microbial testing (to check the cleanliness of the room). For example, let’s say a new manufacturing room has just been constructed, cleaning has been done, and manufacturing is ready to start. But first, let’s make sure the room is within specification by temperature mapping, particle counts, and microbial testing.

The manufacturing and storing of your product is an enormous undertaking for a company. The product is the bread and butter of the company, and the environment that it is manufactured in and stored in has to be impeccable and within its regulations per GMP (Good Manufacturing Practice). Several issues could arise if the environmental specifications are not met. Your product could be stored in a room where the temperature became too high for an extended period. There could be a significant amount of microbial contamination within a manufacturing room that was supposedly cleaned. There could be too many particles floating in the air as well. Any of these issues could mean loss of the product and timing complications in getting your product out because now more testing needs to be conducted to ensure that the product wasn’t compromised. If you have a system of checks, the environmental compromises become minimal.
Environmental monitoring clean room

Best Practices

The following process can be put into your environmental monitoring standard operating procedure (SOP) to minimize any issues with compromising your product:

    • Standard Operating Procedure – Have in place a procedure describing how your environmental monitoring will be conducted. The SOP details when monitoring happens, how many times (a schedule), and what will occur each time. These specifics will vary if the room is for manufacturing or storing. It’s good to create a form for each testing to keep good records. Have a section on what to do if there is an excursion from the specifications.
    • Temperature Mapping – temperature devices are spread out evenly throughout the room, and the temperatures are logged at specific intervals and for a certain period. This procedure ensures that the temperatures are within range continuously across the environment.
    • Particle counts – This process uses a particle counter to determine the number of particles in the air inside the room.
    • Microbial Sampling– This is the process of making sure that cleaning within the rooms is being done correctly. Microbial sampling indicates how many different microbes are growing within the room. Surface testing involves touching agar plates on areas such as tables, equipment, and walls to test for bacterial growth. Air sampling is performed by leaving agar plates in different parts of the environment for a defined period. The standard operating procedure should state what qualifies as passing and failing the environmental monitoring test.
Make sure to create forms for each test and to make sure and explain what the plan of action is if there is a failure in the room. Environmental monitoring is a vital part of your manufacturing. Putting this in place is a part of the success of the company. It is another way to keep the product from being compromised.

Authored by Ashley Castro, PSC Biotech® consultant

Edited by Crystal McClain, PhD

 

PSC Biotech® has engineers and professionals to assist with Environmental Monitoring. As a global leader specializing in Engineering consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance. Also, see our equipment rentals section for CLiMET® particle counters and air samplers and more! 

We look forward to hearing about your needs in Engineering and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online.

For a deep dive into microbial contamination control, read our white paper on the subject!

Download the PSC Biotech® Microbial Contamination Control White Paper

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Table of Contents

    • Introduction
    • Control Priorities
    • Personnel
    • Procedures
    • Facility Design
    • Monitoring
    • Summary
    • Acknowledgements

As a global leader specializing in Engineering consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance. Also, see our equipment rentals section for CLiMET® particle counters and air samplers and more! 

We look forward to hearing about your needs in Engineering and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online.

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Download the Microbial Contamination Control White Paper today!

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Background

Validation of pharmaceutical manufacturing processes became a cGMP expectation in the early 1980s. For many years afterward, “Validation” consisted of two related but separated activities:

  1. Qualification of designated facilities, equipment, utilities, etc.
  2. Validation of manufacturing processes and supporting procedures such as equipment cleaning, sterilization of components, etc.

There are understood overlaps between the two activities, such as equipment requiring qualification prior to process validation runs. However, Qualification and Validation were usually the responsibility of separate, and often siloed, technical disciplines. Engineers and technicians qualified facilities and equipment. Afterward, process scientists and production operators ran process validation studies. Often, there were no formal mechanisms for communicating process requirements to design/project engineers or documented traceability to the Quality department for approval to implement the requirements.

ICH Q9 and the 2011 FDA Process Validation Guideline

In the last 10-15 years, a dramatic shift occurred in Qualification and Validation practices. Previously, many pharmaceutical industry practices were based on anecdotes, individual company experiences, and “precedent”. Since the 2007 publication of ICH Q9, and the FDA’s subsequent update of its 1987 Process Validation Guidance for Industry in 2011, updated Qualification and Validation practices have become known as “science and risk-based approaches”. These modern approaches utilize the well-established science of Quality Risk Management (QRM) as described by  of ICH Q9 Quality Risk Management.

Application of QRM principles has broad implications for all areas of GxP operations, including but not limited to:

    • Commissioning and Qualification (C&Q)
    • Process Validation (PV)
    • Corrective and Preventive Action (CAPA)
    • Preventative Maintenance
    • Instrument Calibration
    • Change Control
    • Training
    • Other
C&Q in Process Validation
In the arena of Process Validation, the FDA’s 2011 Guidance for Industry – Process Validation: General Principles and Practices integrated previous FDA process validation guidance with the QRM principles of ICH Q9 and established a three-stage “lifecycle” approach to achieving and maintaining a validated state. See the diagram for an overview of the Process Validation lifecycle. A validated state means a demonstrated and documented state of process control.

Specification, design, delivery and installation are part of the lifecycle, as is verification, or Commissioning and Qualification (C&Q). They are not C&Q itself, but prerequisite activities. The FDA Process Validation Guide designates C&Q as the first phase of Stage 2 Process Qualification, commonly referred to as “Stage 2a”. An ASTM Standard, ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, details a risk-based approach to C&Q based on the ICH Q9 principles. The FDA Process Validation guidance suggests that the ASTM E2500 is “useful” in describing FDA’s expectations regarding how industry is to perform an activity in a science-and-risk-based manner compliant with ICH Q9.

These three documents: ICH Q9, FDA Process Validation Guideline, and ASTM E2500, will inform our further discussion of how C&Q fits into the overall Process Validation Lifecycle.

Where C&Q Fits Into the Validation Lifecycle

The diagram below depicts the 3-Stage FDA Process Validation Lifecycle with the activities and data of each stage or phase.

C&Q in Process Validation

QRM Implications for Facility and System Design – Critical Aspects

Process User Requirements are the specifications that facilities and equipment must satisfy to ensure their fitness for intended use, and are developed in Stage 1 Process Design. The functions, features, abilities, and performance characteristics necessary to ensure consistent product quality and patient safety are referred to by ASTM E2500 as Critical Aspects.  The ASTM further states that Verification (C&Q) activities should focus on these aspects of manufacturing systems, providing documented objective evidence of meeting predetermined test/inspection criteria. Check out our previous blog discussing the “how-to” of identifying Critical Aspects using risk assessment tools.

Summary and Conclusions

    • In the shift to risk-based Qualification and Validation processes, the functions and features of GMP-relevant facilities and equipment systems needed to ensure the quality and patient safety of a new or redesigned pharmaceutical product are identified as part of the “Process Design” Stage (Stage 1) of the FDA Process Validation Lifecycle.
    • Stage 1 development knowledge, data, and process experience are used to establish a specific set of Process User Requirements that help ensure product quality and patient safety.
    • Technical Subject Matter Experts (SMEs) perform a risk assessment to identify risks to meeting Process User Requirements from the manufacturing process and systems. SMEs also evaluate design solutions and risk control plans as they involve facility/system designs.
    • Critical Aspects of facility/system design are risk controls that are engineered functions and features of facilities and equipment designs.
    • Risk controls must be verified (through commissioning, qualification, or both) to be installed and operating per design for the facility/system to be considered fit-for-purpose.

Authored by: David Dolgin

Edited by: Crystal McClain, PhD

About PSC Biotech®

Outsourcing using PSC Biotech® Engineering consultants enables you to hire proficient and experienced engineers in Commisioning and Qualification on a project basis. PSC Biotech® has over 25 years of experience in C&Q consulting for life sciences companies and consultants available worldwide. PSC Biotech® Commissioning, Qualification, and Validation (CQV) Engineers are available to:

    • Installation and operational qualifications (IQ/OQ) for Building Management System (BMS) Systems and Environmental Monitoring Systems
    • Development and assessments for maintenance programs
    • Detailed Operational Qualifications
    • Process Validation (PV)
    • SOP development and preventative maintenance implementation
    • Turnover documentation package preparation
    • Compile the CQV Issues Log
    • Finalize the project with a CQV Summary Report (CQVSR)
    • … and more!

Contact us today for a tailored, budget-friendly, quote!

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PSC Biotech welcomes Justin Jay as COO

PSC Biotech welcomes Justin Jay as COO

December 13th, 2021 | Pomona, CA (USA)

The PSC Biotech® Board of Directors has promoted Justin Jay to Chief Operating Officer (COO) as of December 10, 2021. Justin comes to the COO role after serving as PSC Biotech’s Director of Technical Operations. Justin joined PSC Biotech two years ago as the Director of Mid-Atlantic Operations and has quickly proven to be invaluable to the organization. As an operations and business development executive, Justin brings skills and experiences that align well with PSC Biotech’s priorities – spearheading and executing time-sensitive clinical and commercial manufacturing initiatives for global pharmaceutical, biotechnology, and medical device organizations.

Justin brings nearly 20 years of operations and business development experience in the private and public sectors as COO of PSC Biotech.

With a career devoted to life science, Justin has first-hand experience in almost every aspect of the business – from research and development to clinical project management to manufacturing operations to commercial oversight. His diversified background, entrepreneurial spirit, and agile adaptivity allow Justin to deliver operations leadership, sales management, strategy, and innovation that optimize projects of all sizes, complexity, and duration for success.

Justin’s prior experience includes serving as a project and portfolio management leader for global biologics manufacturing sites, directing late-stage drug development projects for major international pharmaceutical companies. Furthermore, Justin has experience designing project management infrastructures that seamlessly incorporate into more comprehensive global development planning efforts.

Justin Jay COO

An adept cross-team facilitator with a successful track record in developing, optimizing, and scaling projects and technologies, Justin’s background is making a significant contribution to helping PSC Biotech work effectively under aggressive timelines, challenging logistics, and complex requirements.

PSC is delighted for Justin to join the Senior Management team alongside our Chief Executive Officer and other corporate officers.

 

Congratulations on your appointment as COO, Justin Jay!

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Quality Metrics – A Look at Your Company’s Health

Quality Metrics – A Look at Your Company’s Health

It is always good to know how your company is doing. Whether monthly, quarterly, or yearly, company metrics are a great tool to determine what is working and what needs some work.

What are metrics?

A metric is a report that displays how your company is doing in every aspect. For example, product count, the number of deviations, time for closing out deviations, complaints, documents, and those are just a few examples. Depending on how often you want a picture of how the company is doing, your metrics will find the gaps. These metrics reports should be reported to the entire company, which will allow everyone to know how the company is doing and where improvements need to be made.

quality metrics

Types of Reports

Quarterly metrics are the most common, splitting the year into four equal blocks and thus, allows the company to see how they are doing every three months. The following are reports that can be used in the companies’ metrics:

    • Product – Amount of goods made, the quantity of each product produced, what batch records have been released, why batch records have not been released, and how long it takes to make a batch.
    • Investigations – Number of deviations, the root cause of deviations, the total number of deviations opened and closed, how many days to close out a deviation, number of corrective and preventative actions (CAPAs), the root cause of CAPAs, length of time to close CAPAs, and what keeps these reports open.
    • Documents – Number of new documents created, the types of documents created, the number of revised documents and documents up for review, how many documents have been approved or have not been approved, and the number of days a document is open and closed.
    • Training – How many employees are overdue on training, how many trainings have gone out, and how long the training takes to complete.
    • Equipment – What equipment has been calibrated, upcoming equipment calibrations, equipment that has been taken out of service, and why.

These reports provide a lot of information about how your company is doing as a whole. Usually, a quality assurance team member will compile all the reports and present them to the managers and the rest of the company.

The overall progress that the company makes comes from knowing what works and what doesn’t. The metrics are a visual way of seeing how the company is performing, and if some areas need improvement, the metrics will show where those improvements are needed. Companies should always be looking at the progress of their company.

PSC Biotech

Quality Control Experts

PSC Biotech® can assist and complete the metrics for your company.

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