1. How many years of experience does PTL have in particle characterization?
The laboratory staff at PTL has over 50 years of combined experience in the science of particle technology. The analysts have had hands-on training in particle size, surface area, density, and other physical characterization techniques. This training, along with the knowledge of the theory, makes the laboratory staff at PTL an invaluable resource for your particle characterization needs.
2. What is the process to have my samples analyzed at PTL?
As the client, before sending in your samples, complete the Sample Submission Form (SSF) and obtain a purchase order or credit card information for billing. Send the samples, SSF, and any other pertinent information to PTL. Upon receipt of the samples, PTL will log the samples into their in-house tracking system where the samples will be assigned a unique project number. If a specific analysis is not requested, a trained analyst will determine which instrumentation is most appropriate for the sample type. After the instrument is selected, the analyst will determine an appropriate method for analysis. Upon completion of the analysis and review of the data, the preliminary data will be faxed or emailed to the client. A complete report will follow in the mail, along with the original data pages.
3. What information can we provide to aide in the analysis of the samples?
PTL requests that a Material Safety Data Sheet (MSDS) is sent along with the samples if available. Other useful information would be melting point for surface area analyses, solubility information for particle size analyses, and any special handling instructions for all analyses.
4. Are our samples analyzed according to validated test methods or specific guidelines?
All samples are analyzed in accordance with cGMP guidelines. The analysts are trained in method development, instrumentation, theory, and detection ranges to determine the best method for your sample type. However, unless requested by the client, the methods are not validated.
5. Are samples outsourced to other laboratories for analysis?
Certain analyses are not performed in-house at PTL and must be outsourced. PTL will inform you if your samples will be subcontracted to another facility. If the samples are subcontracted, client confidentiality will be maintained.
6. What accreditations does PTL have?
PTL has been registered with the FDA for 10 years, is licensed by the DEA to handle schedule II through V drug substances, and has a permit with the ATF to handle pyrotechnics.
7. Does PTL have a separate Quality Assurance team?
Yes, PTL has a separate Quality Assurance Unit (QAU) which monitors the established quality systems within the laboratory. The QAU is also responsible for all client audits.
8. Is the laboratory equipment verified?
Yes, the laboratory instrumentation is verified on a quarterly basis by a trained analyst. The verifications monitor the performance of the instrument using a known standard for that instrumentation type.
9. If I receive unexpected results or results that are out of specification, how do I ensure they are valid?
We recommend that you send specifications with each sample set. That way, we are immediately notified of an unexpected result. A laboratory investigation is then launched to determine if the result is true or aberrant. In this manner, we ensure that results submitted to you are valid.
10. What is the turn around time for routine analyses?
PTL has three levels of turn around time. Standard turn around time is 10 business days to receive a faxed or emailed copy of your preliminary data. Final reports are sent via First Class Mail within one week of the preliminary data. PTL also offers two priority status turn around times, 100% RUSH and 50% RUSH. If you select 100% RUSH, for the majority of our instruments, preliminary data can be sent within 2 business days. If you select 50% RUSH, for the majority of our instruments, preliminary data can be sent within 6 business days.
