Introduction

This survey is intended to address aseptic processing practices for secondary manufacturing (finished product filling/packaging) throughout the world.

The intent of this survey is to update the previous PDA surveys on "Current Practices in the Use of Media Fills in the Validation of Aseptic Processing". The first PDA survey instrument was developed in 1986 by J. Agalloco and B. Gordon (patterned after an earlier survey developed by Michael Korczynski for PMA in 1981) and was submitted to member firms in the fall of that year. PDA surveyed the industry in both 1991 and 1996. The results of the 1991 survey are published in the Journal of Parenteral Science and Technology (Volume 47, No. 2, Supplement S1, 1993), while the 1996 survey appears in "Current Practices in the Validation of Aseptic Processing–1996,” PDA Technical Report No. 24 (PDA Journal of Pharmaceutical Science and Technology, Volume 51, No. 2, Supplement, 1997). During the preparation of PDA Technical Report No.22 and the tabulation of the 1996 survey, it was recognized that the periodic assessment of aseptic processing technology was of significant value to the industry in understanding current attitudes and practices with regard to this important area. The results of the 2001 PDA survey were published in “Current Practices in the Validation of Aseptic Processing–2001,” PDA Technical Report No. 36 (PDA Journal of Pharmaceutical Science and Technology, Volume 56, No. 3, Supplement, 2002).

One of the major benefits of surveying on a regular basis is the opportunity to follow the evolution of concepts and practices over time. This survey incorporates new issues, including questions from the 2003 PQRI survey, and topics arising from recent PDA Aseptic Processing workshops.

A total of 197  multiple choice questions is included that encompass many different aspects of aseptic processing. 

Where firms have APAs at one or more sites, please complete one survey for each site that has APA manufacturing (finished product filling).  Please do not consolidate results from multiple sites within your firm, since many of the issues are site-specific in nature and consolidation may adversely affect the accuracy of the data. We ask you to complete the survey by June 30, 2017.

PDA will publish the data in the latter part of 2017.  In addition, PDA will use this data in formulating PDA comments to any pertinent draft regulatory publications. 

Throughout the document, there are terms that may not be interpreted uniformly.  For this document, please use the following definitions:

·       Campaign:  A series of consecutive production batches manufactured without intervening cleaning and sterilization; processing of multiple lots or batches of the same product serially in the same equipment.

·       Critical surfaces:  Product contact surfaces, indirect product contact surfaces, surfaces within Grade A (e.g., inside filling line).

PDA conducts its benchmarking surveys in a manner designed to protect the confidentiality of the gathered information and data. The identity of survey respondents will be blinded and not revealed to the Task Force members, or in any publication or presentation of the results of the survey.

You may request a PDF version of the survey by emailing your request to scireg@pda.org.  Please include PDA 2017 Aseptic Processing Survey in the title of the e-mail, and we will e-mail a copy to you.  Feel free to distribute the survey to others in your organization who may want to participate as well.

Your participation in this important industry activity is greatly appreciated.

Richard M. Johnson
President & CEO

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