Analytical Contract Lab Providing Particle Size and Characterization Testing Services

PTL Now offering USP 788, USP 789, and USP 787 Testing

Particle Technology Labs is pleased to announce we are now offering:
 
USP <788> Particulate Matter in Injections testing,
USP <789> Particulate Matter in Ophthalmic Solutions testing, and
USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections testing.
 
 
Parenteral drug infusions for intramuscular, subcutaneous or intravenous (IV) injection should be virtually free of subvisible particles that can be harmful when introduced to the bloodstream. To ensure these products meet or exceed standards, particles are detected and measured using light obscuration analysis or microscopic inspection after capturing the particles on a filter.
 
USP <788> Particulate Matter in Injections
 
The USP <788> Particulate Matter in Injections general chapter is used to determine the count and size of undissolved particles in injection solutions ≥ 10 and ≥ 25 µm. This general chapter provides an overview for the use of two procedures; Method 1, Light Obscuration Particle Count Test, and Method II, Microscopic Particle Count Test. Chapter <788> of the United States Pharmacopeia (USP) is harmonized with Chapter 2.9.19 of the European Pharmacopoeia, and Japanese Pharmacopoeia. These standards apply to most small- and large-volume parenteral products.
 
Method 1
 
Light Obscuration Particle Count Test is used to examine injections and parenteral infusions for subvisible particles, other than gas bubbles, unintentionally present in the product. A vial or a pooled sample of vials from the product are sampled by the instrument in a clean environment.  The instrument measures the number and size of particles in the injectable formulation and the results compared to USP requirements.  PTL’s instrument is performance verified on a routine basis to ensure counting and sizing accuracy specifically for this important test.
 
In some cases, it may be necessary to further test some products by the Microscopic Particle Count Test to prove conformance to requirements. For example, products that produce air or gas bubbles when drawn into the sensor, are of high viscosity, or are optically opaque may require microscopic particle count testing. The Microscopic Particle Count Test is also used to reach a conclusion on conformance to the requirements if an unexpected result is obtained from the Light Obscuration test.
 
Method 2
 
Microscopic Particle Count Test is conducted by retaining particulate on a membrane filter for examination under a microscope. The filter is then scanned visually by a trained chemist using a microscope with proper illumination capabilities. The observed particles are compared against a USP defined reticle to determine if they are ≥ 10 and ≥ 25 µm. The microscopy count test is used for unique products which are not appropriate for Method 1 or as a secondary check for unexpected results from the Light Obscuration Test. Should a sample have reduced clarity or increased viscosity, such as in emulsions, colloids, or liposomal preparations for example, Method 2 should be utilized rather than Method 1.
 
USP <789> Particulate Matter in Ophthalmic Solutions
 
Ophthalmic solutions are used in the treatment of eye conditions and the determination of foreign particles in these products is of obvious importance to prevent irritation and possible damage to a patient’s vision in extreme cases. This general chapter is closely related to USP <788> in that the same analytical techniques are used, however a ≥ 50 µm size criterion is added to the product acceptance criteria.
 
USP <787>, Subvisible Particulate Matter in Therapeutic Protein Injections
 
Investigating protein aggregation phenomenon is required to evaluate shelf life, stability and efficacy. USP Chapter 787 outlines testing of more sensitive therapeutic protein formulations and allows a smaller sample volume testing framework to address proteinaceous particles in samples with small volume dosage forms. Protein injections are often only available in single milliliter dosages, so their testing requires modified USP 788 testing procedures.
 
For questions, or to find out more about this, or other particle size and characterization testing at PTL, please contact our sales team by calling (630) 969-2703, or visit us online at www.particletechlabs.com.
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

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.

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."