Analytical Contract Lab Providing Particle Size and Characterization Testing Services
Rebecca Wolfrom,  Methods Compliance Specialist

Methods Validation, Verification and Transfer with Particle Technology Labs

What is a method validation? Should my method be verified? What scope of testing should be included in my method transfer? These are just some of your questions. Let Particle Technology Labs help with the answers.


PTL is pleased to offer method validation, method verification, and method transfer services governed by industry standards as you prepare your submission to regulatory bodies such as FDA. As stated in the FDA Guidance for Industry “Analytical Procedures and Methods Validation for Drugs and Biologics” dated July 2015, analytical method validation is defined as “the process of demonstrating that an analytical procedure is suitable for its intended purpose.” FDA Guidance for Industry is a self-stated complement to “International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology,” which is in turn harmonized “to the extent possible” with USP <1225> “Validation of Compendial Procedures”.


As stated in USP <1226> “Verification of Compendial Procedures,” verification is recommended for procedures being “performed for the first time” to show they “yield acceptable results utilizing the personnel, equipment, and reagents available.”


As stated in USP <1224> “Transfer of Analytical Procedures,” method transfer is a documented process to ensure a lab can conduct a newly introduced procedure with “the procedural knowledge and ability to perform the transferred analytical procedure as intended.” Method transfer may be conducted to show comparative testing, covalidation between two or more laboratories, or revalidation and ensures consistency. In the case of a method change due to an instrument retirement, PTL offers protocol-driven method transfer with repeat testing.


When you request one of these services, a methods specialist will work with you during the entire process from protocol development to report sign-off, ensuring your approval is sought throughout. PTL’s rigorously trained chemists will use cGMP qualified instrumentation per USP <1058> to conduct the work. Once concluded, a comprehensive report package is released which thoroughly summarizes the method study performed, the results achieved, as well as other supporting documentation.


The majority of the analyses conducted at PTL (including particle size and surface area) fall into Category III as defined by USP<1225>. Category III procedures require the evaluation of precision during validation. Other parameters may be required depending on the method and goals of the client. PTL typically suggests evaluating accuracy by reference material analysis and microscopy digital image capture of the test material, robustness by design of experiments, method precision (repeatability), and intermediate precision (comparison of chemists and/or days and/or instruments, as resources allow). We defer to your needs for the final decision.

To read more about methods validation, verification and transfer from PTL, click here

Standard Methods for Examination of Water and Wastewater at PTL

Standard Methods for Examination of Water and Wastewater at Particle Technology Labs

The water industry is one of many industries that relies on PTL for important scientific data. Flood studies, filter determination, and verifying compliance with water quality standards are just a few ways that water analysis results are utilized. Our most popular techniques for water analyses include Single Particle Optical Sensing (SPOS) / Light Obscuration and Nanoparticle Tracking Analysis.

For a list of analyses offered under the Standard Methods for the Examination of Water and Wastewater visit https://www.particletechlabs.com/…/astm-iso-and-usp-meth…/sm

PTL Receives ACIL Customer Quality Service Award

The American Council for Independent Laboratories (ACIL) has announced Particle Technology Labs as a recipient of the ACIL Customer Quality Service Award for 2019. This is PTL's seventh consecutive year in qualifying for this award.

The ACIL Customer Quality Service award program was developed in 1996 to recognize laboratories with exemplary quality performance. 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.
 
To participate in the program, laboratories must distribute satisfaction surveys to customers, maintain proof of an annual ethics-training program and an early detection system for questionable analytical practices, and submit a signed code of ethics. 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 successfully qualify into this program. Thank you to all our customers who provided honest feedback regarding our particle characterization services. 
 
For more information about this award, or for any of the services offered at PTL, please visit our website at http://particletechlabs.com or contact us at (630) 969-2703.


Some comments from our customer satisfaction surveys include:

"A responsive, well-coordinated team."

"I've been working with PTL for five years now, and I have always received great customer service."

"PTL is an excellent lab to work with!"

"I have been thorougly impressed by the performance of the PTL team and organization since day 1!"

"Consistently excellent performance."
 
"PTL delivers on their commitments on timing and will beat the time if possible."

"I wish every lab operated like PTL."

Particle Technology Labs' Elizabeth Fitzgerald Gives Presentation in Amsterdam

Particle Technology Labs' Particle Chemist III / Team Leader Elizabeth Fitzgerald just returned from the Netherlands where she was one of three presenters at The Center for Professional Advancement's course entitled, Powders: Their Properties and Processing. The three-day event took place December 9th through December 11th, 2019, in Amsterdam.


The primary purpose of the course was to "review the various properties of powdered solids pertinent to the development and manufacture of the products of the pharmaceutical, cosmetic and allied industries." While the course was designed for those in product development, the event was attended by scientists, suppliers and technologists.


During the three-day course, Ms. Fitzgerald presented on the following topics:


In her first session, Characterization of Powder Particle Size, Shape, Flowability and Density, Ms. Fitzgerald discussed particle size basics, particle sizing techniques, powder flowability and powder densities.


In her second session, Fine Particle Characterization: Dynamic Light Scattering (DLS), Nanoparticle Tracking Analysis (NTA) and Zeta Potential, she discussed fine particles, Brownian Motion, and the latest techniques for fine particle characterization.


In her third and final session, Characterization of a Particle's Surface and Pores, she discussed surface area determination, pore size and distribution measurement, and surface texture measurement.


Elizabeth Fitzgerald joined PTL as a Particle Characterization Chemist I in 2014, before eventually advancing to her current position as Particle Characterization Chemist III, and Team Leader in the Laser Diffraction department. Ms. Fitzgerald works closely with PTL clients and chemists to ensure the highest degree of analytical integrity, with a specific focus on laser diffraction techniques and instrumentation. Her current responsibilities include test method development and instrument qualifications. She is also actively engaged in laboratory training, assisting with the implementation of safety programs and procedures.


The Center for Professional Advancement - CfPA is the largest accredited technical training organization in the world offering technical training and continuing professional education courses to those in the pharmaceutical, biotechnology, medical device, chemical engineering and cosmetics industries.

PTL ISO/IEC 17025:2017 Accreditation Complete

Particle Technology Labs, the premier particle characterization service laboratory and advisory company is pleased to announce a change in accreditation status from ISO/IEC 17025:2005 to the most updated ISO/IEC 17025:2017 criteria. From the ISO.org website, “In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.”
 
ISO/IEC 17025 is an internationally recognized quality standard for calibration and testing laboratories. Accreditation to this standard asserts that the laboratory is competent to conduct specific testing as detailed on the certificate of accreditation. For an organization to be ISO 17025 accredited, its facility must undergo a rigorous independent assessment which evaluates the quality management system, training practices, testing programs, and instrument maintenance processes.
 
 
This accreditation assures PTL customers that laboratory operations, personnel training, equipment calibration, maintenance, and operation and quality assurance systems are in compliance with ISO/IEC 17025:2017 requirements.
 
 
 
“Particle Technology Labs is dedicated to providing the highest quality service to our customers. One way that we do this is to continually improve and build upon our laboratory practices and quality systems. Securing this accreditation is only a part of the commitment that we keep to our customers, providing the best value and highest standards in particle characterization services.” 
 
– Richard J. Karuhn, President
 

The International Organization for Standardization (ISO) is an independent, non-governmental international organization that provides “requirements, specifications, guidelines or characteristics that can be used to ensure that materials, products, and services are fit for their purpose.”(1)  To visit ISO online, click here:https://www.iso.org/home.html.
 
 
 
Particle Technology Labs is a proven cGMP (current Good Manufacturing Practices) compliant laboratory, in accordance with 21 CFR, Part 210 and 211. Our facility is FDA registered and inspected, and we host over 30 audits per year from the world’s largest pharmaceutical companies. We are DEA licensed and approved to handle Schedule II through V controlled substances. We also maintain an ATF permit for analyzing pyrotechnics. To visit Particle Technology Labs online, click here: https://particletechlabs.com/.
 
 
 
 
 
  1. Retrieved from https://www.iso.org/standards.html