Valiteq Aspectic Technique Verification System 1-800-433-7698

 

Validation Studies

The following are published studies that define and demonstrate the effectiveness of the VALITEQ Aseptic Technique Verification System in supporting the CSP process:

  1. Using a medium-fill simulation to evaluate the microbial
    contamination rate for USP medium-risk-level compounding.

    View validation study.
    Trissel, L. A., et.al., Vol 62. 285-288,
    American Journal of Health-system Pharmacy (AJHP), February 2005

  2. Potential for airborne contamination in turbulent- and
    unidirectional-airflow compounding aseptic isolators.

    View validation study.
    Peters, G. F., et al., Vol. 64, 622-631,
    American Journal of Health-system Pharmacy (AJHP), March 2007
  3. Effect of two work practice changes on the microbial
    contamination rates of pharmacy-compounded sterile preparations.

    View validation study.
    Trissel, L. A., et.al.,Vol. 64, 837-841,
    American Journal of Health-system Pharmacy (AJHP), April 2007
  4. Achievement of USP Chapter <797> Compliance
    by a 35-Bed Rural Hospital: A Case Study.

    View validation study.
    Peters, G. F., et. al.,Vol. 11-6,
    International Journal of Pharmaceutical Compounding (IJPC),
    November - December 2007
  5. "INSTRUCTIONAL DESIGN AND ASSESSMENT: Parenterals Laboratory Course to Reduce Microbial Contamination Rates in Media Fill Tests Performed by Pharmacy Students."
    View validation study.
    Christine M. Isanhart, PharmD, et al., 72(2), 1-4, Article 27.
    American Journal of Pharmaceutical Education. April 2008.

Additional Literature

 

Laminar Airflow Equipment Theory and Applications
Peters, G. F.
Swarbrick J, ed. Encyclopedia of Pharmaceutical Technology 3rd ed. Vol. 4. New York: 2007. Informa Healthcare.

View study.

Microbiologic Monitoring of Controlled Processes
Peters, G, and McKeon, M.
Swarbrick J, ed. Encyclopedia of Pharmaceutical Technology 3rd ed. Vol. 4. New York: 2007. Informa Healthcare.

View study.

View the ASHP Dicussion Guide for Compounding Sterile Preparations.

View the General Chapter <797> Pharmaceutical Compounding - Sterile Preparations Status and Update.

View A Practical Guide to Aseptic Technique Verification.

View the 2006 CETA Compounding Isolator Testing Guide.

Use the Gap Analysis Tool.

View NIOSH on Exposure to Antineoplastic Drugs.

View OSHA's technical manual on Controlling Exposure to Hazardous Drugs.