ARL Bio Pharma is a high-quality laboratory who partners
with compounding pharmacies and outsourcing facilities. 
June News and Updates
Microbial Limits for Nonsterile Pharmaceuticals

Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described in three major Pharmacopeias.

USP <61> Microbiological Examination of Non-Sterile products: Microbial Enumeration provides tests used to determine bioburden present in raw materials, during production, and in the finished product. This microbiological test determines the total population of aerobic bacteria and yeast and molds that might be present in pharmaceutical ingredients and finished products.

USP <62>  Microbiological Examination of Non-Sterile products: Tests for Specified Organisms
provides tests used to check for the presence of objectionable microorganisms that could cause the patient harm based on variability in the route of administration. This microbiological test verifies the absence of objectionable microorganisms in drug products and raw materials based on route of administration.

USP <1111> Microbiological Examination of Non-Sterile products: Acceptance criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use lists acceptance criteria for microbiological quality of nonsterile dosage forms including: route of administration, total aerobic microbial count, total yeast and mold count, and absence of specified microorganisms.

The microbial limit for nonsterile products must be within an acceptable range that does not pose health hazards to intended patient groups or diminish product stability. 

To learn more about Microbial Limits for Nonsterile Pharmaceuticals, visit our article links below. 


 
Visit ARL's website to learn more about the testing services available for nonsterile products. To request a quote email:  info@arlok.com.    
USP <800> Webinar Q&A

Click here to read Webinar QA
In May 2017, Dr. Kupiec presented a session "USP 800 & Environmental Monitoring Requirements" for the American College of Apothecaries Educational Center. 

Our laboratory received several questions during the webinar and provided answers during the Q&A session.  

To access on-demand webinar recording, click here
Register for ARL's August Webinar today!



















Register for An Inside Look at USP <71> on August 8, 2017 12:00 PM CDT at:  https://attendee.gotowebinar.com/register/6137331353369476611
Have you registered for the Quality Compounding Summit?
 
The Quality Compounding Summit is taking place in Oklahoma City, Oklahoma, September 8-9, 2017. This educational conference is in partnership with American College of Apothecaries. 

Industry leaders will speak on key topics including best practices, safety, facility design, and regulatory issues.
 
Who's attending?
Compounding Pharmacists, Pharmacy Technicians, Board of Pharmacy members, Board of Pharmacy inspectors, and leaders within the compounding industry.


Speakers
  • USP <800> California Board of Pharmacy Implementations: How Pharmacists Can Incorporate USP <800> into Facility Design - Tony J. Park, PharmD, JD, California Pharmacy Lawyers 
  • Root Cause Analysis for Compounding Pharmacists - Joe Cabaliero, RPh, Gates Healthcare Associates, LLC
  • Coping with the Changing Compounding Landscape - Loyd V. Allen, Jr., PhD, RPh, International Journal of Pharmaceutical Compounding
  • Microbiology Testing: USP Requirements for Sterile and Non-Sterile Preparations  - Thomas C. Kupiec, PhD, ARL Bio Pharma
  • Beyond Use Dating - Thomas C. Kupiec, PhD, ARL Bio Pharma
  • Multistate Pharmacy Inspection Blueprint Program - State Boards of Pharmacy Regulatory Landscape for Inspections of Compounding Pharmacies  - Elizabeth Scott Russell, RPh, National Association of Boards of Pharmacy
 
Register today! www.qcsummitrx.org 
  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 07/31/2017.
(June Newsletter) 
STAY CONNECTED: