Standard Guide for Evaluation of Cleanroom Disinfectants

Importancia y uso:

5.1 Requirements for aseptic processing areas include readily cleanable floors, walls, and ceilings that have smooth, non-porous surfaces; particle, temperature, and humidity controls; and cleaning and disinfecting procedures to produce and maintain aseptic conditions. These controls, combined with careful and thorough evaluation of the chemical agents used for the cleaning and disinfection program, should lead to achieving the specified cleanliness standards and control of microbial contamination of products. Qualification of disinfectants in pharmaceutical, biotechnology, medical device facilities, and associated controlled environments, along with validation of the cleaning and disinfection process, is subject to scrutiny by regulatory agencies.

5.2 An effective cleaning and disinfection program in aseptic processing areas of a Good Manufacturing Practice (GMP) - regulated facility is critical to assure product quality. Manufacturers are held to a high standard when it comes to product sterility, and regulatory agencies increasingly request validation data to support sanitization and disinfection procedures. Regulatory authorities expect evidence of the effectiveness of disinfection agents against environmental microorganisms isolated from the facility. The FDA Guideline for Aseptic Processing states, “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.”7

5.3 Basic knowledge regarding the effectiveness of different chemical agents against vegetative bacteria, fungi, and spores will aid in selecting chemical agents.

5.4 An understanding of test methods used to assess disinfectant effectiveness is important. Most methods are adaptable, allowing the user to customize the methods to their specific requirements.

Subcomité:

E35.15

Referida por:

E2756-24A, D8219-19, E3106-22, D8270-23B, D8270-23B, E3418-23E01

Volúmen:

11.08

Número ICS:

13.040.35 (Cleanrooms and associated controlled environments)

Palabras clave:

carrier tests; cleanroom; disinfectant; disinfectant qualification; efficacy; in situ testing; suspension tests;