Risk considerations for the installation of a new pharmaceutical facility autoclave

Abstract

This article considers some of the risk considerations that need to be accounted for when replacing a steam sterilization autoclave within a pharmaceutical processing facility. In outlining the key risk considerations, the article adopts a risk assessment approach – Failure Modes and Effects Analysis (FMEA).

This is an edited extract from the book “Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies” by Tim Sandle, available from the PDA Bookstore at:
https://store.pda.org/ProductCatalog/Product.a spx?ID=3329

Introduction

This article considers some of the riskconsiderations that need to be accounted forwhen replacing a steam sterilization autoclave within a pharmaceutical processing facility. In outlining the key risk considerations, the article adopts a risk assessment approach – Failure Modes and Effects Analysis (FMEA).

An autoclave is a pressure chamber used to sterilize equipment and supplies by subjecting them to high pressure saturated steam(Sandle, 2013). Autoclaves are used within pharmaceutical facilities to eliminate microbial cells and spores from within a given device. Autoclaves commonly use steam heated to 115–134°C (250 273°F). To achieve sterility, a holding time of at least 30 minutes at 115°C, 15 minutes at 121°C (250°F) or 3 minutes at
134°C (273°F) is required (Hugo, 1991).

The validation and verification of the sterilization process is well monitored in the pharmaceutical industry and operators must ensure that autoclaves comply with various guidance and regulations. Nonetheless, the purchase of a new autoclave and the assessment requires evaluation. An additional dimension is added when one autoclave is being used to replace another, as with the case study discussed here. To make such an evaluation, a formal risk assessment is required under the auspice of quality risk
management.

Risk management and risk assessment principles should be applied as early as possible during the design and construction of steam sterilization devices. With steam sterilization devices the most critical functions
are, arguably, the steam sterilization of direct and indirect the product contact parts. A second important aspect relates to air removal. All of the trapped air must be removed from the autoclave before activation. This is
because trapped air is a very poor medium for achieving sterility.