Process Solutions Flow Distribution in the Pharmaceutical/Medical Device Industries

Process Solutions Flow Distribution in the Pharmaceutical/Medical Device Industries

Oct 28, 2021 | Be Meticulous, Blog

Critical plant systems such as reverse osmosis and chemical distribution systems can bring production down when they go down.  Over time plant utility usage can change, and previously reliable systems will have events that lead to production losses, regulatory compliance issues, and equipment downtime.

If you are in the pharmaceutical, biotechnology, or healthcare industries, you need to have properly maintained, calibrated, and validated equipment and facilities, not just for regulatory compliance but for reliable and profitable operations. To optimize current distribution systems, you need to do proper assessments, procedural changes, system repairs, and validation addendums.

flow mapping

What are the tests performed process solutions distribution?

Common tests/assessments for distribution systems include:

    • Flow/Pressure Distribution Test (System in recirculation (no utility usage)
    • Flow/Pressure Distribution Test (Maximum usage)
    • Temperature Distribution Test (Points of Use)
    • Maximum Supply Flow
    • Minimum Return Flow
    • Power Loss Tests
    • Alarm Tests
    • Recovery Time Tests

Other tests to consider based on your risk assessment include

    • Sensor Response Time
    • Control Loop Tuning
    • Dead-leg evaluation
    • Micro testing
    • Distribution Tank Switchover Testing
    • Emergency Generator Cutover Tests
    • Routine Use Tests

How is Process Flow Mapping done?

Process Flow mapping involves placing an array of pre-calibrated flop, pressure, temperature, and other parameter data-logging sensors in pre-defined locations on generation, distribution, and points of use.  You start the data-logging sensors and run the tests specified in your approved validation study protocol.  You want to run the process solutions flow validation study long enough to go through the various flow loading equipment, and end-users cause varying demand.  After the Process Solution Flow mapping study, the sensors are post-calibrated to assure that the sensors are still operating as expected.

How long does process flow mapping take?

A process flow mapping study takes one to two weeks, including the time to prepare and approve the protocol, pre-calibrate the sensors, the actual testing, and the post-calibration of the sensors.  Typical thermal mapping study execution times are in these ranges.

  • Solution Mixing and distribution tank(s) (run duration processing through generation and distribution of all tanks)
  • Distribution Loops (1 Week)
  • Points of Use (24 Hours to 1 Week)

Results

The Process Solutions Flow mapping output is flow, pressure (and other parameters) versus time report at each location.  The final study report demonstrates that your equipment or facility can meet your specifications when you operate it as you intend to operate it.

PSC Biotech is the right Process Solutions Flow mapping service

If you need Process Solutions Flow mapping services, calibration services, and state-of-the-art wireless or wired equipment to do thermal mapping validation of your equipment and facility, contact PSC Biotech. Our process solutions flow mapping experience and supply of calibrated state-of-the-art wireless and wired sensors can meet all your Process Solutions Flow mapping needs.

 

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Equipment Calibration – Keeping Your Equipment in Top Working Order

Oct 2, 2021 | Be Meticulous, Blog

When thinking about the heart of the company, the equipment that produces your product must come to mind. Without good working equipment, your products may become compromised and hurt the company’s reputation for producing good quality products. Let’s say that during a manufacturing process, the scale that was used had gone out of calibration. The product has now possibly been compromised because the scale may not be working within its specifications. Keeping your equipment calibrated is very important to ensure that the products coming from your company are top quality.

Any equipment used to produce, check or inspect your product should be working correctly and within specification. Depending on your companies’ policies, your equipment should be calibrated at least once a year to ensure it is working properly. Equipment gets used and moved around several times, which can cause the equipment to become out of specification and could start to cause problems with your production.

In this example, the balance had an expired calibration and was used to weigh the material for production. Since the balance was out of calibration, the question became whether the appropriate amount of each material was added. Was there too much? Or was there not enough added? Now not only has your product possibly compromised, but you also have a deviation on your hands. Let’s look at what you as a company can do to keep your equipment working accurately.

equipment calibration

First of all, your company needs to put a Standard Operating Procedure (SOP) for the equipment, stating when and how many times a piece of equipment gets calibrated. Label each piece of equipment with the calibration due date so that operators know when it becomes overdue and not to use it. A great tool to incorporate is to have an equipment log with all your equipment and their calibration due date, that way, you can plan when to send out a piece of equipment. It is an excellent idea to have a backup for your equipment, so production is not on hold because the equipment is out for calibration. Alternatively, add a section in your batch records and forms for the equipment calibration date, which should catch if the equipment is still within its calibration.

Properly working equipment means your product is being produced at a high quality, and that’s what you want. Adding checks is one way to keep your equipment running smoothly and to ensure that no equipment is out of calibration.

How PSC Biotech® can help you calibrate

PSC Biotech® provides metrology services to calibrate and test for your laboratory equipment. We meet the requirements for yearly proficiency testing. Contact us for more information on how our metrology services can help you.

We are seeking to understand more about the metrology needs of people who visit our website. Please consider filling out our survey so that we may increase our capacities in areas of interest: here.

 

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Applying Quality Risk Management (QRM) to C&Q Planning

Sep 30, 2021 | Be Meticulous, Blog

Since the publication of ICH Q9 “Quality Risk Management,” applying the principles of Quality Risk Management (QRM) as part of Pharmaceutical Quality Systems is an expectation of global regulatory agencies. The effective application of QRM requires a significant degree of planning and preparation. This blog article discusses the integration of QRM into the planning process for Commissioning and Qualification (C&Q) of “Direct Impact” pharmaceutical and biopharmaceutical facilities and equipment systems.

In 2001, ISPE published “Baseline Guide 5 – Commissioning and Qualification”, which proposed a systematic mechanism called “Impact Assessment” to determine if an equipment system was GMP-relevant and had the potential to directly impact product quality. This seminal risk-management document preceded ICH Q9 publication by four years and began the “science-and-risk-based approach” to Equipment Validation and Qualification. The science-and-risk-based approach is summed by this ICH Q9 core principle: “The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk”.  Because not all facilities or systems impact product quality and not all aspects of design and function are equally critical, risk identification and prioritization are required to implement ICH Q9 QRM principles in the planning of C&Q activities.

Here we outline the steps to applying QRM in C&Q planning:

Applying Quality Risk Management (QRM) to C&Q Planning

Initiating the C&Q process:

    1. Identify a team of Subject Matter Experts (SMEs) familiar and knowledgeable about both the equipment or facilities and their intended uses/functions and the manufacturing process to be supported.
    2. Define and document the description of the change, the scope of work, and the reason and justification for change(s). Most pharmaceutical manufacturing organizations will already have an established process for such changes, including the designation of required approvers.

For each system involved with the planned change:

    1. Perform a preliminary screening for potential quality impact using high-level tools such as a Preliminary Hazards Analysis (PHA), ISPE System Impact Assessment, or a similar documented methodology. Changes or systems that have little or no quality impact potential should not require formal Qualification.
    2. For systems with “Direct Impact,” select an appropriate risk assessment tool (e.g., FMEA) to identify specific failure modes and the necessary risk mitigations or controls.
    3. The controls and mitigations based on engineering design aspects, for example, alarms and interlocks, are the “Critical Aspects” and must be demonstrated and documented (verified) as being present and operating as designed in the installed and operational system. The Critical Aspects should be documented and approved by the Quality unit and designated SMEs.

For complicated, multi-system projects:

    1. An overarching C&Q Plan is recommended to consolidate the quality information regarding a C&Q project and answer the following questions if they do not already exist in the firm’s SOPs.
    2. Which Quality System (QS) requirements are applicable based on project definition and scope?
    3. What aspects of the new or modified facility or system require Qualification, and what is the rationale for any exclusions?
    4. Will the use of properly documented (GDP-compliant) commissioning work meet Qualification requirements in lieu of repeat testing against a pre-approved protocol?
    5. How will nonconformances be handled?
    6. What are change control rules during project execution? If they differ between “Project Change Control” and “Operational Change Control,” at what point do routine Operational Change Control rules re-apply?

Summary

    1. QRM must be used to accomplish C&Q and Validation Master Plan (VMP) planning to fully realize the Science-and-Risk-Based Approach advocated by U.S. FDA and many international regulatory agencies.
    2. Simple “screening” tools such as the ISPE Quality Impact System Assessment checklist can separate and identify systems with potential product quality impact from non-GMP systems such as environmental control, waste management, or non-GMP packaging equipment.
    3. Once you identify “Direct Impact” systems, standard risk assessment methodologies, such as Process Hazard Analysis, Fault Tree, and FMEA, can identify specific design and engineering- based risk controls required for each system, called “Critical Aspects” by ASTM E 2500.
    4. Critical Aspects for each system inform the design, specification, and testing. Also, Critical Aspects define the parameters for approved as Qualified for clinical or commercial use, and therefore must be included in protocols and comprehensive planning documents.

Find Experts

PSC Biotech® applies QRM to C&Q on every level. The risk-based assessment component is a cornerstone for PSC Biotech®. Our biggest asset to your C&Q process is consulting on QRM. We are more than technicians at your service by additionally bringing specific consulting for problems and complicated systems. Contact us to let us know what you need.

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Sep 2, 2021 | Be Meticulous, Blog

Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the competence of testing and calibration laboratories.

ISO 17025 provides detailed parameters for:

    • Proficiency testing
    • Metrological traceability, including the use of reference materials
    • Uncertainty measurement
    • In-house calibrations
    • Management systems operations
Calibration

Proficiency testing

An essential part of proper proficiency testing is using and maintaining a documented plan for three years of sampling activities. This document needs to include a yearly proficiency test (PT) or inter-laboratory comparison (ILC) covering the appropriate parameters, ranges, measurements, test technologies, inspections, methods, and uncertainty of measurements. You may use a PT/ILC provider if they are accredited to ISO/IEC 17043. However, if you choose to develop your own ILC, you need further approval from ANAB. Furthermore, a successful PT/ILC must be completed within 12 months of applying for ISO 17025 accreditation.

For more information and examples within a specific field and industry testing, see the ANAB administrative process rule (PR). Major fields with related parameters for testing scopes can be found in PR 2350, Preparing a Draft Scope of Accreditation for Testing Laboratories.

Metrological traceability

All testing and calibration results must be traceable whenever possible through NIST or another National Metrology Institute (NMI) to the International System of Units (SI units). This means that your metrological traceability, in order of preference, is through an NMI directly, an ISO/EIC 17025 accredited laboratory, using intrinsic standards, or from a weights and measures lab. Applicant and accredited laboratories should use ISO/IEC 17025 accredited calibration laboratory services whenever available. Acceptable ISO/IEC 17025 accredited calibration laboratories are those accredited by ANAB or another accreditation body that is a signatory of the International Laboratory Accreditation Cooperation (ILAC) MRA with the appropriate calibration services listed in the scope of accreditation. If your organization seeks to submit reference standards and equipment to a calibration provider not covered by the traceability hierarchy above, the laboratory shall use the ANAB FM 2808 and apply for the approval of that non-accredited calibration provider. To trace your metrology, use form FM 2807, the traceability and in-house calibration tracking document.

Metrological traceability using reference materials

Reference materials need to fall under:

    • Certified Reference Materials (CRMs) from a reference material producer (RMP) accredited to ISO 17034
    • Standard Reference Materials® (SRM) from NIST (called under trademark).
    • CRM from another National Metrological Institute (NMI). Use of any CIPM-active NMI may be acceptable.
    • The certified values assigned to CRMs are covered by entries in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.

If you cannot obtain reference materials from those sources, other authoritative sources or reference methods, or materials from internal validation may be used—document validation of the materials and methods and equipment. For information on Uncertainty Measurement, see the ANAB guidance documents.

In-house calibrations

If you are already ISO 17025 accredited, ANAB allows you to calibrate your own equipment according to your document plan. In accordance, you will:

    • Have the appropriate environment for carrying out the calibration.
    • Appropriately trained personnel to both carry out and check the calibrations.
    • Demonstration of competency to perform the undertaken calibrations.
    • Reference standards, certified reference materials, or reference measuring instruments are traceable with appropriate measurement uncertainties.
    • Documented procedure for each type of calibration.
    • Appropriate means of recording and reporting the data and results of any calculations according to the requirements of ISO/IEC 17025.
    • Estimate, evaluate, and maintain records of uncertainties for traceability realized internally that support tests associated with the scope of accreditation.
    • Complete Form 2807, the traceability and in-house calibration tracking document.

Management systems options

As with quality assurance, your calibration and testing need to be documented, controlled, and tracked thoroughly. One option (A) is to independently meet all the specifications put forth in ISO 17025. The other option (B) is to use a management system that conforms to ISO 9001.

Industry specifics

There are different accreditation requirements set forth by the ANSI National Accreditation Board (ANAB) for:

    • Testing laboratories
    • Calibration laboratories
    • Stand-alone sampling organizations
    • Dimensional Measurement laboratories

To apply for ANAB accreditation for ISO 17025, you will need to detail the items of concern and their measurements. There are different reporting requirements for the varying fields. They are as follows:

Testing laboratories concerning:

    • Acoustics
    • Vibration
    • Biological
    • Microbiological
    • Chemical
    • Construction Material
    • Electrical, Mechanical
    • Non-Destructive
    • Optical
    • Photometric
    • Radiometric
    • Product Safety
    • Thermal
    • Subsurface Munition
    • Information Technology

Need to itemize measurements with the following information:

    • Major field
    • Specific Tests and/or properties measured
    • Specification, standard, method, or test technique
    • Items, materials, or products tested
    • Key equipment or technology

Electromagnetic Compatibility (EMC) or Radio need to itemize the test method (date/revision), test specification(s), range, and any additional comments.

Environmental laboratories need to itemize the technology, specification/standard method/test technique, and analyte.

Calibration and Dimensional Measurement laboratories need to itemize:

    • Parameter/equipment
    • Range
    • Expanded uncertainty of measurement (+/-)
    • Reference standard, method, and/or equipment

Sampling organizations need to itemize:

    • Items, materials, or products sampled
    • Component, parameter, or characteristic sampled
    • Specification, standard, method, or test technique

Follow-up

ANAB has additional, industry-specific requirements for ISO 17025 accreditation for laboratories involved in:

    • Forensics
    • Environmental
    • Food and feed testing
    • Telecom and electronics
    • Calibration
    • Aerospace
    • Cannabis testing
    • Other, non-categorized programs

How we can help

PSC Biotech® has more than 25 years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us for more information on how our metrology services can help you in ISO 17025 accreditation.

We are seeking to understand more about the metrology needs of people who visit our website. Please consider filling out our survey so that we may increase our capacities in areas of interest: Metrology Survey.

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The Complete CQV: Where to Start

The Complete CQV: Where to Start

Aug 26, 2021 | Be Meticulous, Blog

CQV engineer

Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In this article, we’re focusing on an over-all CQV instance, involving the launch of a new or significantly modified product is involved rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). In both cases, though, modern CQV practices are informed by a number of industry/regulatory guidelines including:  

    • ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)”
    • U.S. FDA “Process Validation: General Principles and Practices”
    • ICH Q9 “Quality Risk Management”
    • ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”

Phase I

The first phase of a comprehensive CQV effort is to finalize the required User Requirement Specifications (URS), and Risk Assessments (RA). Quality Risk Assessments by Subject-Matter-Experts (SMEs) in the process at hand provide risk control strategies and the necessary engineering controls. Once a control strategy has been defined, the Validation Master Plan (VMP) can be developed. The VMP is a high-level document that identifies the amount and sequence of commissioning, verification, and validation activities associated with the Project.  This document captures the CQV strategy and is a living document that is revised throughout the project’s lifecycle to maintain the correct strategic approach for achieving regulatory compliance. 

Additionally, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents are leveraged to accelerate the completion of the project, and they are based on the outcome of the risk assessment (RA). Thus, the Validation Master Plan will incorporate: 

    • Determine the extent of leveraging permissible based on risk assessment per system.
    • Alignment of construction-management inspection test plans and forms.
    • Review of completed inspection test plans.
    • Review of vendor FAT protocols.

CQV with risk in mind

A science-and-risk-based approach to CQV is a current Good Manufacturing Process (cGMP) requirement. Understanding risk assessments and associated control plans helps define your quality risk management process, which is essential for maintaining quality assurance and adhering to regulatory mandates. Risk Assessments will be critical in determining what aspects of the commissioning and verification effort represent the highest risk. Therefore, your engineers will focus the verification efforts to determine the appropriate level of commissioning and qualification testing and documentation performed for each system and equipment. 

CQV engineers review all the project specifications and documentation, focusing on floor plan layouts, equipment and utility piping and instrumentation diagrams, User Requirement Specifications (URS’s), and other documents that specify requirements to be tested/or documented during commissioning.  Based on these specifications, the CQV engineers develop a conservative, risk-based approach for commissioning and qualification using the already developed System Impact Assessment (SIA) as a starting point.  

Next

Check out other blog articles in our CQV series where we will tell you more about the Validation Master Plan. Then watch for future CQV articles on Phase two of a CQV project – the execution phase performed onsite and remotely. On-site, engineers document and test equipment, facilities, utilities, computer systems, processes, and cleaning. Preparing onsite components is the core component of CQV projects, and we look forward to elucidating this process.  

CQV Engineers and Project Managers

PSC Biotech® Commissioning, Qualification, and Validation Engineers and Project Managers are available to:

    • Develop the Validation Master Plan.
    • Complete Gap and Risk Assessments.
    • Perform Pre-Startup Safety Reviews.
    • Generate, perform, and document the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
    • Execute a System Impact Assessment (SIA).
    • Provide 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).

Furthermore, unless otherwise requested, PSC Biotech assigns a Project Manager to each CQV project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute CQV projects in a highly efficient manner to get your product started as soon as possible. See our project success pages for examples. Contact us for a bespoke assessment and cost estimate.

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Metrology 101

Aug 11, 2021 | Be Meticulous, Blog

Why you need a calibration program

Metrology is the scientific study of measurement.

If you make things, you need to calibrate the buildings, equipment, and processes that you use to make things.

If it moves or measures and doesn’t breathe, it might need calibration. Your calibration program identifies the critical items that need calibration, the items that are for information only, etc.

If you can’t measure it, you can’t calibrate it.

Calibration

Once you decide what needs calibration, you need to determine what measurements you need to make. Your calibration program establishes the tolerances, the calibration interval, and the measurement data that you or your calibration service providers must generate for “it,” whether “it” is your buildings, your equipment, or your process(es).

Whether you do it yourself or have calibration service providers do it for you, your Quality Assurance group is ultimately responsible for your calibrations. If you use a service provider, use one that has current Good Manufacturing Practice (cGMP) experience.

You Might Need Verifications

Once you calibrate, you can perform verifications. Verifications are your in-process checks performed on the floor during the calibration interval to ensure that “it” is still in calibration. Not everything needs verification.

How Do I Decide if I Need Verifications?

Do a criticality assessment of your system to identify which things need verification and which do not. Your criticality assessment should take into account measurement systems that affect Quality Control data or customer requirements. How critical is the parameter, e.g., the temperature, mass/volume, pressure, etc., being measured? Suppose you have determined that the parameter in a step is critical to the quality attributes, perhaps even a Critical Control Point (CCP), of your product or process. In that case, you may want to design a verification for that step.

Calibration versus Verification

Calibration uses a reference standard at least four times, and usually ten times or more, accurate than the tolerance you set for whatever you are calibrating. This ratio of the accuracy of the standard to the working device is the total accuracy ratio or TAR. For example, if your process requires a ± 4 RPM for a mixer or centrifuge, then the reference standard needs to perform at a stated accuracy within ± 1 RPM.  Calibrations are done by members of your Metrology staff or your service provider who are adequately trained via the appropriate procedures.

Verification uses a working standard that is suitably accurate to show that the item you are verifying is within the tolerance that you set for it. You want the verification standard to be accurate, robust, easy to use, and give you a “go-no go” result in a short time so that you can get back to processing. Verifications are done by your production personnel on the floor in the plant and recorded on batch records or similar documentation.

 Calibration

    • Performed at regular intervals as defined in your Quality System
    • Performed for troubleshooting when a measurement is outside of expected operating readings
    • Calibration label on the device states the date of performance and the due date
    • Displays a legible calibration sticker traceable to documentation

Verification

    • Designed into the process and performed during manufacturing or periodically
    • Done before use to identify equipment operating outside of expected performance
    • Recorded in pre-operation or batch records
    • Part of the equipment logs, batch record, etc., for the equipment, process, etc.

Summary

You need a comprehensive program for calibration and verification of your facility, equipment, and process(es). When deciding how to incorporate equipment into your calibration program, criticality and risk assessments are best practices, especially surrounding attributes critical to quality.

PSC Biotech has years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us now! PSC Biotech®

If you found this material relevant, please take a moment to share how you manage calibration at your site(s): Metrology Survey

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