R Kraft (RKI)

We provide 3rd party cleanroom certifications to current industry guidelines and recommended practices in either "As-Built" -"At-Rest" -"Operational" mode of operation as well as the Test/Certification of Laminar Flow Devices.

We provide Audits/Benchmarking/Performance Appraisals of existing cleanrooms/cleanspaces to assist you in developing a "go forward "action plan to get your space to your desired goals or for investigative studies. We have the capabilities of providing particle counting on the following channels; 0.1 - 0.3 - 0.5 -1.0 - 3.0 - 5.0 - 10.0 - 25.0 - 40.0 - 50.0 and 100 Microns.

We provide Data Analysis of Air Velocity, Particle Counts, Temp/RH, Pressures for trending purposes.

We provide 5S - Lean/Six Sigma consulting services to enhance the efficiency of the cleanroom production process

129 Shorecliff Dr Rochester, NY 14612
Tel: 585-621-6946

PharmTech News Articles

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.