Patrycja Sitek, owner of CR Konsulting (CRK), biotechnologist and chemist by education, PhD student at the Faculty of Physics, University of Silesia, 9 years of work in an ISO5 class clean room in pharmacy, 5 years of activity in the field of training and education in ISO 14644 requirements, Coordinator for QMS in the BBMRI.pl project of the Polish Biobank Network, Trainer at TUV Nord, IRCA ISO 9001: 2015 Lead Auditor Supporting member of the Technical Cleanliness Association, lecturer at the 'Technical Cleanliness Officer' Postgraduate Studies
What can we do for you?
We will design, implement and equip your clean room
We will train and implement GMP, ISO 9001, ISO 13485 and GLP quality systems
We will prepare a User Requirements Specification (URS) for you,
We will prepare a room division for you adapted to the requirements of the technological process
We will train you to work in a clean room in accordance with the requirements of ISO 14644
We will provide clothing and sanitation solutions, materials for washing and disinfection as well as furniture equipment because we cooperate with
leading supplier - Vileda Professional - on the clean room market in Poland
We will offer a sanitation service to achieve the ISO cleanliness class of your clean room - we work with companies with extensive experience in this type of services
We will perform the full Clean Room qualification after construction, at rest and in operation, along with the delivery of a professionally prepared OQ operational qualification report that meets all the requirements of ISO 14644 and GMP
We will offer you help at every stage of work, as well as provide a solid backup for your company when you start working in a controlled zone at full speed
We will conduct an audit of compliance with the requirements of the PN EN ISO 14644 standard and a cleanliness audit for compliance with VDA 19.2 of your clean room and prepare a full report indicating compliance and potential for improvement
Behind us is almost 5 years of experience in the pharmaceutical, medical devices, dietary supplements, automotive, and electronic, aviation and optical industries. We are there wherever the highest dust and microbiological purity is required.