Analytical Contract Lab Providing Particle Size and Characterization Testing Services

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New Advanced Particle Characterization Instrument at Particle Technology Labs

Dynamic Imaging at Particle Technology Labs

Advanced Particle Sizing and Characterization

Particle Technology Labs is pleased to announce the recent installation of our newest dynamic image analyzer; the Malvern (Sysmex) FPIA-3000.
Many times, particle size distribution analysis provides sufficient information about sample material. However, in cases where the shape of raw material particles can affect performance and quality of the end product, more detailed information may be needed. For these applications, automated image analysis provides thorough and accurate particle shape characteristic measurements.

With the ability to analyze tens of thousands of particles per second, this state-of-the-art automated imaging instrument not only measures particle size, but also defines and characterizes particle shape to report detailed variation in particulate.

While instruments such as laser diffractors size particles, it sees them only as spherical. Automated imaging instrumentation has the ability to not only size particles, but also detect and enumerate agglomerates, oversized particles and contaminant particles. It can measure the size of non-spherical particles such as needle-shaped crystals, providing length and width measurements, and can detect physical properties such as transparency. It can also differentiate between individual components within a mixture.

Automated imaging works by using a high-resolution digital camera to capture images of dispersed sample particulate. Using digital thresholding techniques, images of particles are automatically and objectively measured, analyzed and classified for inclusion/exclusion. In reporting, images are displayed together with particle size and shape data, providing a very effective visual verification of results.

Our newest system, the Malvern (Sysmex) FPIA-3000 provides a robust statistical measurement of particles in a sample as a whole. Compared to manual microscopy, automated imaging analyzes a larger amount of sample in a shorter amount of time, reducing operator subjectivity. This leads to more reliable and accurate results.

This new instrument joins PTL's advanced particle characterization automated imaging instrument, the Malvern Morphologi G3 system. Visit our Image Analysis page on our website for more information.

PTL Receives ACIL Customer Quality Service Award for its Fifth Consecutive Year

PTL is proud to receive the ACIL Customer Quality Service Award for the fifth consecutive year.

This program provides users with a mechanism for evaluating testing laboratories.  Participants are committed to ensuring the integrity of data, meeting customer’s quality needs and setting the standards of performance for the testing laboratory industry.
 
Any testing laboratory who wants to be recognized as a participating laboratory must maintain proof of an annual ethics training and an early detection system for questionable analytical practices, submit a signed code of ethics and distribute satisfaction surveys to their customers.
 
The participants have committed to a uniform code of ethics and Customer Survey data for comparison to other participants.  The Customer Quality Service Award participants demonstrate that they are proud of the quality they achieve and always operate with customer service as a top priority.
 
We are pleased to once again qualify into this program. Thank you to all our customers who provided honest feedback regarding our particle characterization services.

Q & A with Shane Hill of PTL’s Method Services Department

The method services business has grown significantly in recent years. PTL is pleased to provide these services to form stronger relationships with our pharmaceutical clients and help them achieve their goals.

At the helm of PTL’s validation department is Shane Hill, Methods Compliance Assistant Manager. Shane took time from his schedule to answer a few questions about the method services available at PTL.

1. What are method developments, method validations, and method transfers, and what does each entail?

A method development is a process whereby an analytical procedure is created for a specified sample type. Clients will either submit a sample with no established test document or they will provide a nominal procedure that covers a given characterization technique (particle sizesurface area, etc.), and PTL will tailor the method through detailed evaluations. A design of experiments (DOE) is then undertaken, during which several method parameters are investigated for their significance in affecting the results. The DOE data are processed via statistical software; the method is updated to incorporate the optimized settings and a proof of concept is executed to demonstrate precision of the new method.

A method validation is a process which is ideally initiated following varying degrees of method development. Validations are intended to demonstrate that an analytical procedure is suitable for a given sample type. For physical analyses, the testing typically consists of accuracy, precision, and robustness. Accuracy serves to illustrate the trueness of the data within the specified range of interest. Precision demonstrates repeatability of generated data; often validation studies at PTL examine precision across multiple days, chemists, and instruments for a comprehensive comparison. Robustness evaluates the impact of small method variations on the final results.  Data are compared against USP acceptance criteria and/or client-provided specifications, as well as processed via statistical software which reports means, equivalencies, and comparative variability.

A method transfer acts as a precision study between instruments, such as when an older generation instrument is retired and a test method requires transferring to a newer generation instrument, or between laboratories. PTL has extensive experience with both scenarios.  Typically, testing is conducted concurrently across instruments/laboratories, and the data are compared against acceptance criteria. Accuracy is often included as a measure of system suitability.

Across all our method services, PTL follows industry and regulatory guidances in the development and execution of the testing.

2.  How long, on average, does each service take to complete?

Method developments take about 3-4 weeks to complete, from initial evaluation to reporting. Method validations take about 4-6 weeks (depending on the inclusion of robustness and sample difficulty). Method transfers take about 3-4 weeks to complete, from protocol creation to reporting.

3. How does each service benefit the client?

Foremost, PTL’s method services help our clients comply with the FDA’s cGMP regulations.  A robust method development ensures that the analytical procedure provides optimized, linear data for the sample material. Method validations benefit our clients by allowing a test procedure to undergo several levels of precision testing to ensure correlation across several variables, such as days, chemists, and instruments. If robustness is evaluated, then there is the added benefit of demonstration of an optimized method. Method transfers allow a test method to seamlessly be updated to a newer, more efficient particle characterization instrument or to PTL if the transfer is from an outside laboratory.

4. Are there any related services that we offer?

In addition to developments, validations, and transfers, PTL also offers method verifications. Often clients will require a test procedure to be verified against a USP Chapter or Monograph; PTL will design a protocol that includes references to the USP guidelines and will perform the verification testing accordingly. Most often this testing includes a repeatability evaluation, but can include more elements depending on the USP Chapter or Monograph involved.

To read more about how PTL’s method services can benefit you, click here.

“We have been working with PTL’s Methods Service Department for many years and the client service has always been great in terms of technical knowledge, answering e-mails promptly, and quick turnaround of quotations and method transfer reports.”  – Rajat Gandhi of CPL, Ltd."

PTL at the US Power Plant Water Treatment Conference

Water is just one of many industries that turn to PTL for expert particle size and characterization testing. Water particulate is tested for many reasons including determining the characteristics for health and environmental purposes. Particle Technology Labs will be attending the US Power Plant Water Treatment conference in Chicago on September 12th and 13th. The conference brings together industry figures within the US power industry to discuss pertinent issues facing water management. For more information about the conference, visit https://www.lmnpower.com/

Regulatory Compliance

Regulatory compliance is a necessary aspect of quality control in nearly all industries including pharmaceutical, food and beverage, ceramics, petrochemical and more. To comply, companies turn to PTL to perform standardized testing governed by national and international standards organizations including ASTM, ISO and USP. Please contact PTL to discuss any standardized tests required by your industry. For a listing of our most commonly performed regulated analyses, click here to visit our our “Standards and Methods” page.