November 2017 - In This Issue:
Media Fill Testing
A media fill test is required by United States Pharmacopeia (USP) and state boards of pharmacy to prove that the aseptic technique process can produce a sterile product without contamination. According to USP <797>, any person engaged in sterile compounding must conduct a media fill test:
  • Before beginning sterile compounding for three consecutive days to simulate repetitive process competency.
  • At least annually for low to medium risk compounding.
  • At least semi-annually for high-risk compounding.
Personnel should perform the media fill test under the most stressful and challenging conditions at the pharmacy. 
Media fills use sterile microbiological growth media in place of the drug product and simulates all production operations including:
  • Preparation and assembly of product containers
  • Transfer of product to the fill area
  • All process steps downstream from the sterilizing filter up to product release including packaging into finished product containers 
Learn More


ARL  of f ertwo potenctest options, non-cGMP and  cGMPfor determining the concentration of the active pharmaceutical ingredien(API) in compounded preparations.

Specific to the analyte of interest (typically the API) based on USP guidelines for system suitability data such as retention time of the standard and sample, peak shape and absence of interfering peaks in the diluent / blank chromatogram.

Specific to the analyte of interest (typically the API) based on USP and FDA guidelines for system suitability data such as ability of the method to detect the analyte in the presence of impurities and matrix components in the specific drug product formulation.

Published or internally developed methods
Internally developed and validated or verified externally validated methods (e.g. USP)

System Suitability
ARL performs system suitability using one reference standard per API to verify the analytical method's performance.

ARL performs system suitability using two reference standards per API to verify the analytical method's performance.
Reference standards are typically secondary standards. Secondary standards are often qualified as USP grade and are obtained from reputable vendors. In some instances reference standards may be provided by the client.

USP or other primary reference standards are used. Each test also includes a secondary standard or a duplicate preparation of the primary standard as the quality control standard.
Certificate of Analysis
Certificate of Analysis states the general analytical method (e.g. HPLC) used to perform the test and includes the following statement: 

The method(s) used for testing passed system suitability requirements per ARL SOP
AMP-012 for non-cGMP analysis. Product specific method validation is not available for this sample and specification(s) are for informational purposes only. Client should verify the specification and analyte reported are correct for the compounded formulation.

Updated November 13, 2017
Certificate of Analysis includes a reference to the validated analytical test method number
(e.g. AMI-XXXX).

No statements are added as the methods are validated specifically for the formulation tested and the specifications are established by the client.

If you have questions regarding availability of cGMP test methods, stability indicating methods, or other questions, please contact ARL at 405-271-1144 or

Extending Beyond Use Dating and Batch Release Testing: 
Considerations for Your IV Room
An educational symposium sponsored by Omnicell

The practice of assigning beyond use dates for compounded sterile preparations (CSPs) is complicated and often misunderstood. A CSP's beyond use date identifies the time by which the
preparation - once mixed - must be used before it is at risk for chemical degradation, contamination, and packaging permeability.

Join Thomas C. Kupiec, PhD, President and CEO of ARL Bio Pharma, to learn how hospital and health-system pharmacies can use stability and release testing data to improve the preparation and sustainability of sterile compounded drug products. This session will explain general considerations for extending beyond use dates and discuss batch release testing requirements. 

October 5-6, 2018
Oklahoma City, Oklahoma

ARL Bio Pharma and American College of Apothecaries hosted the first Quality Compounding Summit (QCS) in September 2017. This educational conference had 85 attendees, 10 exhibitors, and 7 sessions dedicated to quality compounding. Thank you to our attendees, exhibitors, and speakers. 

Mark your calendars for next year's Quality Compounding Summit! We look forward to another fantastic event in 2018. 
$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 12/31/2017. (November Newsletter)