T. Lypka

For the past three years, Ziva has consulted with me first at Embolic Protection Inc. (EPI), then when it was acquired by Boston Scientific Corporation, Boston Scientific/EPI in the areas of Controlled Environmental Rooms, sterilization, microbial bioburden, general microbiological control and personnel training.

Ziva has extensive experience in most of the areas of microbiology and its application to medical manufacturing for both pharmaceuticals and medical devices. Her troubleshooting knowledge in the area of solving microbiological problems is legendary.

Ziva was instrumental in helping us establish the certification requirements and program necessary for us to start manufacturing Class III medical devices with exceptionally low microbial bioburden counts. Part of this involved training management to deal with the problems associated with microbiology in the start up environment, and the other part was setting up programs to effectively deal with monitoring and educating everyone about microbiology in the CER environment. We had several major issues as we started and Ziva helped us work our way through them without mishap.

Ziva has assumed the role of an instructor and has held numerous training sessions in our facility. The response of the class is always very positive and management has decided to employ Ziva to regularly train CER employees in addition to conducting regularly scheduled audits of the facility and operations to continuously improve our facility.

It has been an honor and a pleasure to have Ziva take the time to assist us in building and developing a highly successful manufacturing operation.

Please feel free to contact me as a reference.

– T. Lypka / Director of Quality Assurance / Boston Scientific / EPI