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J Agalloco

Publications and source records attributed to J Agalloco.

15 recordsLinked to original sources
PubMedDate not supplied

"Points to consider" in the validation of equipment cleaning procedures.

Cleaning validation has received increasing attention by the FDA in recent inspections, yet very little has been published regarding practices within the pharmaceutical industry. This presentation will review several of aspects of the validation of equipment cleaning procedures. A significant portion of the presentation is derived from round table discussions the author has led over the last several years on this subject. Specific areas to be defined include: sampling methods, analytical methods, physical parameters, and of greatest interest, the selection of acceptance criteria. The presentation also includes some additional perspectives on the subject of cleaning validation developed by the author which may prove useful to the practitioner.

Detergents↗
PubMedDate not supplied

Steam sterilization-in-place technology.

Steam sterilization-in-place (more commonly known by its acronym as SIP) is coming into wider usage within the pharmaceutical and biotechnology industries as firms endeavor to increase the level of sterility assurance associated with those products made by aseptic processing. Despite this increase in interest, sterilization-in-place has not been given the attention its growing importance appears to warrant. The intent of this presentation is to define the overall concepts involved with the application of SIP technology and review how these concerns affect specific systems.

Equipment Design↗
PubMedDate not supplied

Opportunities and obstacles in the implementation of barrier technology.

This paper was developed from the keynote address given at the Isolation Technology Users Group (ITUG) meeting held in Raleigh, North Carolina in December of 1993. Present at the meeting were over 100 individuals representing a cross section of users and suppliers. Unfortunately not all suppliers of isolation technology equipment were represented at this meeting. Subsequent to the meeting, ITUG has decided to operate as a special interest group within the Parenteral Drug Association and attendance will be open to all PDA members. I anticipate that the affiliation of ITUG within PDA will facilitate the free exchange of ideas and information among those interested in barrier technology without interference from commercial considerations. My hope is that we can nurture within the industry a common effort among all users and suppliers to overcome the obstacles and realize the opportunities inherent in isolation technology. While it could be construed that certain of my comments represent an endorsement or a chastisement of certain suppliers of isolator systems that was certainly not my intent. It was prepared in a spirit of egalitarianism to assist the industry at large with what I believe to be a technology of great promise.

Drug Contamination↗
PubMedDate not supplied

The validation life cycle.

The Validation Life Cycle is an implementation mechanism which can assist pharmaceutical (and other types of medical product) manufacturers in the organization and execution of validation activities. A considerable body of work exists which identifies how to validate processes of various type and description. Unfortunately, there is a paucity of information on how to organize these individual validation activities into a cohesive whole. This paper describes a suggested means for achieving an organization's validation goals in a rational and effective fashion. To best understand the advantages of a life cycle for validation, a recap of the history of validation in the U.S. pharmaceutical industry is useful.

Computers↗
PubMedDate not supplied

"Microbiological evaluation and monitoring of cleanroom environments" (meeting summary).

It was clear that there was little consensus among the panel with regard to the need for an informational chapter in USP on microbial classification of cleanrooms. The articulated positions of the individual panelists remained essentially unchanged throughout the session. What agreement was achieved was in a willingness to continue the dialogue, to await the outcome of the PDA activities cited above with the hope that a mutually acceptable compromise can be realized through that process.

Drug Industry↗