Patrycja Sitek, owner of CRK, biotechnologist and chemist by education, PhD student at the Faculty of Physics, University of Silesia, 9 years of pharmaceutical practice in an ISO 5 clean room, 5 years of providing training and education on ISO 14644 requirements, Coordinator for Quality Assurance and Management System in the BBMRI.pl project of the Polish Biobanking Network, Trainer at TUV Nord, IRCA ISO 9001:2015 Lead Auditor, Supporting Member of Technical Cleanliness Association, Lecturer at “Technical Cleanliness Officer” postgraduate studies.
Our FB page – https://www.facebook.com/CRK.PatrycjaSitek
What can we do for you?
- We will design, construct and equip your clean room
- We will provide training in and implement GMP, ISO 9001, ISO 13485 and GLP quality systems
- Do you need to prepare technical documentation and clinical evaluation for a medical device? We will do it for you!
- We will prepare the User Requirement Specification (URS), we will assist you in developing the Functional Programme (FP), we will design the layout of the rooms which meets the requirements of the technological process
- We will train you to work in a clean room in compliance with ISO 14644 requirements
- We will provide clothing and sanitisation solutions, cleaning and disinfection materials as well as furniture and equipment from the leading suppliers in the clean room market in Poland who cooperate with us
- We will offer a sanitisation service so your clean room can be ISO classified – we work with companies that have extensive experience in this field
- We will perform a full clean room qualification after its construction, at rest and in operation, and deliver a OQ report prepared professionally and meeting all ISO 14644 and GMP requirements
- We will offer you assistance at every stage of work and provide a solid backup for your business when the work in the controlled area will be in the full swing
- We will audit your clean room for compliance with the requirements of PN EN ISO 14644 and for compliance with VDA 19.2 in terms of cleanliness and prepare a complete report identifying areas of compliance and potential areas for improvement.
We have nearly 5 years of experience in the pharmaceutical, medical device, dietary supplement, automotive, as well as electronic, aviation and optical industries. We provide our services wherever the highest particle and microbiological cleanliness is required.
The effectiveness of our work is confirmed by the references of our satisfied customers
Owner of CRK