Selecting Alert/Action Limits for Environmental Monitoring Programs

JD Wilson - Sterilization of Medical Devices, 2018 - taylorfrancis.com
The two principal purposes of an environmental monitoring program are to provide an
assessment of the general microbiological cleanliness of an operation and to assess the …

[PDF][PDF] Qualification of an environmental monitoring program

S Sutton - Selection/Justification of Sample Sites. Pharm …, 2008 - microbiologynetwork.com
The qualification, or requalification, of an aseptic manufacturing facility depends in large part
on the demonstration of controlled microbial conditions. The following are several areas …

Guidelines for hospital environmental control

BP Simmons, TM Hooton, GF Mallison - Infection Control & Hospital …, 1981 - cambridge.org
Patient-care practices, which usually involve direct personal contact between patients and
staff, are the most important factors influencing preventable nosocomial infections. However …

[BOOK][B] Microbiological contamination control in pharmaceutical clean rooms

N Halls - 2016 - books.google.com
Contamination control in pharmaceutical clean rooms has developed from a jumble of
science and engineering, knowledge of what has worked well or badly in the past …

Statistical analysis of environmental monitoring data: does a worst case time for monitoring clean rooms exist?

AM Cundell, R Bean, L Massimore… - PDA Journal of …, 1998 - journal.pda.org
To determine the relationship between the sampling time of the environmental monitoring,
ie, viable counts, in aseptic filling areas and the microbial count and frequency of alerts for …

Validation of environmental control systems used in parenteral facilities

F De Vecchi - Agalloco J. Carleton F, eds. Validation of …, 2007 - books.google.com
The ECSs play a central role in preventing microbial contamination into sterile products
delivered by the parenteral route. Maintenance of the product's sterility during manufacturing …

Failure analysis in the identification of synergies between cleaning monitoring methods

GS Whiteley, C Derry, T Glasbey - American journal of infection control, 2015 - Elsevier
Background The 4 monitoring methods used to manage the quality assurance of cleaning
outcomes within health care settings are visual inspection, microbial recovery, fluorescent …

Use of audit tools to evaluate the efficacy of cleaning systems in hospitals

RE Malik, RA Cooper, CJ Griffith - American journal of infection control, 2003 - Elsevier
Background: Recent publicity has highlighted both the inadequacies of hospital cleaning
and high levels of methicillin-resistant Staphylococcus aureus infections in UK …

Computer-Assisted Evaluation of Microbiological Environmental Control Data

MP Russell, RN Purdie, JA Goldsmith… - PDA Journal of …, 1984 - journal.pda.org
Microbiological monitoring of “Clean rooms” generates a large number of results, which are
used, in the first instance, to determine that product or patient have not been exposed to an …

Methods for verifying medical device cleanliness

DE Albert - Developments in surface contamination and cleaning, 2015 - Elsevier
Successful cleaning of medical devices and instruments requires both careful selection of
materials and consistent monitoring of the procedures used to process them. Chemical …