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About production

  • Production in clean rooms of 5 and 7 class of cleanliness according to ISO.
  • Highly qualified specialists.
  • Advanced equipment that has passed the validation procedure. 
  • Thorough quality control of products.

SigmaLab is a research and development company whose mission is to develop, prototype and launch mass production of medical devices in liquid form based on biopolymers. Our area is equipped with advanced equipment for preparing, filling, sealing, packaging and sterilizing your products in accordance with GMP and ISO 13485 standards.

We manufacture implantable medical products for various fields such as general surgery, arthrology, oncology, urology, and aesthetic medicine.

Implantable medical devices are classified as hazard class 3 and must be manufactured in ISO class 7 facilities. This means that in such a room the number of suspended particles with a size of 0.5 microns should not exceed 352 000 per m². SigmaLab has clean rooms and advanced equipment, including laminar flow hoods, allowing aseptic filling under ISO class 5 cleanliness conditions. 

SigmaLab capabilities and equipment

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  • Filling in bottles 
  • Filling into syringes 
  • Packing in a rigid blister  
  • Sterilization

Our glass syringe filling and sealing machine is capable to produce 900 pieces / hour, 7 200 pieces / day, 172 800 pieces / month,

2 073 600 pieces / year.

Correct packaging of the goods helps to maintain the quality of the finished product, therefore, upon your order, SigmaLab can carry out packaging of the manufactured products. In a technological warehouse that meets all the requirements for storing medical devices, the finished and packaged goods are stored until they are transferred to the courier service. A product accounting system has been introduced at our warehouse, which allows for full control of incoming raw materials, all internal movements and outgoing finished products.

Quality control

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SigmaLab monitors product quality at every stage of production. The incoming raw materials undergo laboratory tests, and our specialists inspect each finished syringe and bottle after filling the product and before shipping it to the customer. Quality control is an integral part of our production.

Staff

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Our staff undergoes compulsory training when hiring and has a very responsible attitude towards their work. Each employee is aware that humans are the main source of pollution in production and follows all the rules for working in clean rooms to prevent the slightest possibility of contamination. Only qualified engineers and technologists with a high level of responsibility work in our team. 

We would like to note that SigmaLab works with accredited cleanroom laundries and uses textiles that minimize the risk of contamination.

Certification and validation

SigmaLab has been successfully certified by an independent international organization for standardization "ISO" (International Organization for Standardization). As a result of the audit, the company was issued a certificate of compliance with the international standard ISO 13485 valid for 3 years.

Download the certificate of compliance ISO 13485 

© «Sigma Lab», 2020