Evaluation of a rapid microbiological method with a mixed culture biofilm model.

Unlabelled: During the past decade, rapid microbiological methods (RMMs) have continued to make inroads into the pharmaceutical and medical device industries. This has led to the development of guidelines for the validation of alternative microbiological methods for both quantitative and qualitative applications. Many studies regarding RMMs have focused on testing performed with planktonic microorganisms.

Ophthalmic viscoelastic devices as a cleaning challenge.

Common practice when validating the cleaning of medical devices is to employ clinically relevant test soils as a challenge to the cleaning process. During use, medical devices may come into contact with a variety of materials that are difficult to clean. One example of this is the use of ophthalmic viscoelastic devices (OVDs) in cataract surgery.

A designed experiment for evaluation of the OPA method for cleaning studies of medical devices.

This study reports the results of a designed experiment to evaluate the use of the o-phthalic dialdehyde (OPA) method for residual protein, with a testsoilderivedfrom blood, dehydrated hog mucin, and egg yolk, and its application in validating the automated cleaning of surgical instruments in a laboratory setting. The ruggedness and robustness of the OPA method was determined by means of a Plackett-Burman experimental design and assessed the automated cleaning of a microkeratome for use in patients undergoing lamellar resection of the cornea during refractive surgery. The outcome of the study indicates that the OPA method for residual protein is rugged and robust for the factors evaluated and is an effective means for validating the cleaning of complex medical devices under controlled laboratory conditions.

Comparative antimicrobial activity of no-rub multipurpose lens care solutions in the presence of organic soil.

Purpose: This study reports the effect of organic soil on the antimicrobial activity of four commercially available multipurpose contact lens care solutions used in no-rub regimens as determined by a modified International Organization for Standardization 14729 (ophthalmic optics-contact lens care products-microbiological requirements for products and regimens for hygienic management of contact lenses) Stand Alone Test procedure.

Methods: Testing was performed with organic soil consisting of a mixture of heat-killed yeast cells and heat-inactivated bovine serum or these components added separately. The organic soil was mixed with the challenge microorganisms before addition to the solution, added to the solution after addition of the challenge microorganisms, or added to the solution before addition of the challenge microorganisms.