ARL Bio Pharma is a high-quality laboratory who partners
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August News and Updates
Photo courtesy of the US EPA
Particulate Matter: What is It and What are the Concerns?

Particulate matter contamination in injectable drug products, especially in large numbers, can cause harm to patients. Common particulate sources include: solvent impurities, drug precipitates, dust, glass, rubber, environmental contaminants, fibers and other insoluble materials. 
 
The size of particulate matter is an important factor when considering the potential risk to patients. Particles as small as 2 μm in diameter have been associated with microthrombi formation in patients. Dr. Michael Akers with the Food and Drug Administration notes that the smallest capillary blood vessels are considered to have a diameter of approximately 7 μm. Therefore, all particles having a size equal to or greater than 7 μm can conceivably become entrapped in and obstruct capillaries, increasing the potential for adverse effects. Simple visual inspection, which is required for compounded injections, may be adequate for large particles, but is inadequate for smaller particles. The lower limit of visibility of the naked eye is approximately 40 μm. Specialized testing methods are therefore necessary to adequately assess the total particulate burden of injections. 

The United States Pharmacopeia establishes procedures and standards to ensure the quality of intravenous injections, including particulate counts. Compounding pharmacists can reduce the incidence of adverse events in patients by assuring the quality of their preparations through filtration of intravenous preparations and analytical testing procedures.  
 
USP Chapter <788> Particulate Matter in Injections recommends two test procedures for determining particulate matter. These two tests are (1) light obscuration particle count test and (2) microscopic particle count test. The two procedures test for particulate matter in preparations and count particles that are equal to or greater than 10 μm and 25 μm. 
 
The USP guidelines limit particulate matter introduced into preparations and into the patient. USP testing methodologies can assure compounding pharmacists of the quality of their preparations and the quantification of subvisible particles. Pharmacists can use these tools to improve patient safety. 
 
To learn more about Particulate Matter in Injections, click here to read more. 

Visit ARL's website to learn more about particulate matter testing services. To request a quote email: info@arlok.com
An Inside Look at USP <71>

Click here to read Webinar QA
James Zellner, Technical Sales, presented a session "An Inside Look at USP <71>" on August 8, 2017. 

Our laboratory received several questions during the webinar and provided answers during the Q&A session. Attached  is the Webinar Q&A document for more information. 

To access on-demand webinar recording, click here
Register for the Quality Compounding Summit today!

Save $50 off registration with promo code QUALITY 17
Save $50 off registration with promo code QUALITY17


On-line conference registration for the  Quality Compounding Summit  will close on August 28; on-site registration will begin at 7:30 a.m. on September 8.
 
Visit  www.qcsummitrx.org to register. 
  ARL Bio Pharma | (800) 393-1595 | info@arlok.com | www.arlok.com
$25 off your next test

Submit this coupon with your next sample for $25 off your next test with ARL. Cannot be combined with discounts or special offers. 

Offer Expires 09/30/2017.
(August Newsletter) 
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