June 2018 - In This Issue:
Microbial Tests for Non-Sterile Products
Andrew Taylor, Microbiology Supervisor
 
USP <795> states that pharmacists performing non-sterile compounding must ensure that the finished preparation has its accepted potency, purity, quality, and characteristics.  This article discusses the tests described in USP <61> and USP <62> that are used to determine if non-sterile products meet quality requirements.  These tests can also be used by sterile compounders for qualifying raw materials and performing in-process quality control testing. 

Testing Conditions
The general considerations for testing non-sterile products are much like USP <71> Sterility testing. Growth promotion is required to demonstrate that every lot of media will grow the microorganisms required for each test. Method suitability is also performed prior to product testing to establish the ability of the test to detect microorganisms in the presence of the specific formulation to be tested. All testing must be completed under aseptic conditions to avoid extrinsic microbial contamination of the product tested and must include proper positive and negative controls.  

USP<61> Microbial Enumeration Tests
USP <61> is often called "Bioburden" or "Microbial Limits" because the test determines how many microorganisms are present in the sample. To perform the test, the sample is plated onto two types of growth media (Soybean-Casein Digest Agar and Sabouraud Dextrose Agar). The plates are incubated at a defined temperature and duration. At the conclusion of the test, the number of colonies present on the plates are counted and the results calculated. The results can then be compared to the acceptance criteria. USP <1111> can be referenced for acceptable amounts of microorganisms present based on whether the sample is a raw material or finished drug product. If the sample is a finished drug product, the acceptance criteria depends on the route of administration.

Container Closure Testing
ARL now offers fully validated, cGMP container closure testing for:
  • 10mL glass vials with a 10mL fill, rubber septum, and aluminum seal
  • 30mL glass vials with a 30mL fill, rubber septum, and aluminum seal

The cost for 10mL and 30mL vials with a clear drug inside is $250 with a 10 business day turnaround time. 

 

For other vial sizes and fill volumes, request a quote or call 800-393-1595.
Sample Submission Form
Fast Approaching Deadline - July 31, 2018
ARL will no longer process any samples on old sample submission forms after July 31, 2018. All samples arriving at ARL for test results are required to have a sample submission form or submitted online. 

 

Call 800-393-1595 with questions.
Have you registered for the 2018 Quality Compounding Summit? 

Join us October 5-6, 2018 in Oklahoma City!
2018 Educational Sessions:
  • Update on the Development and Revision of USP Compounding Chapters - Jeanne Sun, PharmD, United States Pharmacopeia (USP)
  • Current and Future Trends in Pharmaceutical Compounding - Loyd V. Allen, Jr., PhD, RPh, International Journal of Pharmaceutical Compounding
  • Controlled Environments for Sterile and Non-Sterile Compounding - Kenneth S. Latta, BS. RPh, FIACP, FACA, ProPharma Cleanrooms, LLC
  • Scientific and Technical Challenges in Compounding - Thomas C. Kupiec, PhD, ARL Bio Pharma
  • The Practical Use of the USP as a Primary Reference Resource in the Formulation of Sterile and Non-Sterile Compounded Preparations - Kimberly Kieffer
  • 503A/503B, USP/cGMP, BOP/FDA . . . Examples of Government Enforcement and What Not to Do - Tony Park, Pharm.D., J.D., California Pharmacy Lawyers
     

The Quality Compounding Summit will also have a speaker panel session and a round table discussion.

There are 9 hours of CE for this conference.  


Register today at qcsummitrx.org! 

Contact ARL for more information 800-393-1595 or  [email protected] . 
$25 off
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 7/31/2018. (June Newsletter)
Have you celebrated ARL's 20 years with 20% off?

To thank you for making our success possible, ARL is offering customers:
  • 20% off USP <71> Sterility Tests method suitability
  • 20% off USP <61> Microbial Enumeration Tests method suitability
  • 20% off USP <51> Antimicrobial Effectiveness Testing method suitability
This discount is good through December 31, 2018. 

To take advantage of these savings, visit  arlokapps.com to submit samples online or  download ARL's sample submission form. 

Contact ARL for more information 405-271-1144 or  [email protected]  to request a quote.