Наша ціль

Забезпечуючи хірургів і пацієнтів безпечними та високоякісними аллографтами, ми хочемо зробити свій внесок у розвиток медицини та підвищення якості обслуговування пацієнтів.

“ 

Наша місія - збереження та покращення якості життя пацієнтів. 

Компанія «Probones» постійно розвивається, щоб кожен клієнт був задоволений нашими продуктами та послугами. Ми залучаємо кваліфікованих співробітників та дотримуємось високих стандартів якості.

Генеральний директор

Андрій Барканов

“ 

Наша місія - збереження та покращення якості життя пацієнтів. 

Компанія «Probones» постійно розвивається, щоб кожен клієнт був задоволений нашими продуктами та послугами. Ми залучаємо кваліфікованих співробітників та дотримуємось високих стандартів якості.

Генеральний директор

Андрій Барканов

Барканов Андрій 


Закінчив медичний університет О.О. Богомольця. Навчався в провідних Банках Тканин Європи - Італія, Іспанія, Польща, Голландія. Неодноразовий учасник конференцій Європейської Асоціації Банків Тканин.

Генеральний директор

Андрій Барканов

Безпека

Processing

The possibilities of surgical reconstruction of the musculoskeletal system are constantly expanding, an increasing number of surgeons around the world are using allografts due to their safety, efficiency and ease of use.

Probones’ allografts meet the highest standards in patient care. The allograft processing includes a thorough donor screening and donation of tissue samples, examination in certified laboratories, a standardized tissue cleaning process, sterile packaging, a high-precision quality control system.

Donor screening procedure

Donor screening and donation of tissue samples are carried out in strict accordance with the European Association of Tissue Banks (EATB) standards. Once the donor has agreed, a thorough evaluation procedure is initiated, namely:

  • Analysis of the donor's medical and social history. Individuals with risk factors or clinical evidence of infectious diseases and their causative agents, such as HIV/AIDS, viral hepatitis, sepsis etc. are excluded from being potential donors.

  • Assessment of the donor's physical condition. The accuracy of medical and social history data, risk factors and other disqualifying conditions is checked.

Laboratory tests

According to European Association of Tissue Banks (EATB) standards and Ukrainian legislation, donor tissue samples are sent to independent laboratories for testing for infectious diseases and antibodies or antibody markers such as:

  • Human immunodeficiency virus type 1 antibodies (HIV-1 antibodies / HIV-1 nucleic acid test)

  • Human immunodeficiency virus type 2 antibodies (HIV-2 antibodies)

  • Human T-lymphotropic virus type 1 antibodies (HSV-1 antibodies)

  • Human T-lymphotropic virus type 2 antibodies (HSV-2 antibodies)

  • Hepatitis B virus (HBc antibodies (total) / HBs antigens)

  • Hepatitis C virus (HCV antibodies / HCV nucleic acid test)

  • Syphilis (Syphilis RPR (Anticardiolipin Antibodies Test) / immunofluorescence reaction)

All donors are assessed for blood clotting to determine possible impact on test results.

Tissue cleaning 

The treatment process ensures that the biomechanical properties of each allograft are preserved while eliminating risk to the patient.

Tissues are processed by method and includes chemical and physical cleaning procedures that reduce the amount of bone marrow components and fats that are characteristic of human tissue.

Tissue processing

  • Study of biomechanical properties of allografts

  • Monitoring of freezing and thawing cycles

 

Advantages

  • Sterile allografts

  • Double sterile packaging

Sterile packaging

The sterility of the allografts is guaranteed by careful packaging. The safety and high quality of the allografts is ensured by observing the standards of the packaging process, namely:

  • Double sterile packaging with clear labeling;

  • The outer layer of the package provides protection against moisture and storage at ultra-low and room temperatures;

  • The inner protective layer of the package simplifies the handling of the allograft in the sterile field;

  • The final sterilization of the product takes place after the completion of packaging;

  • Guaranteed three-year shelf life;

  • Instructions for use detailing donor screening, test results and tissue processing;

  • Each allograft has its own personal identification number for quality control.

Quality control of allografts

The processes of careful control of donors, documentation, tissue processing, packaging of allografts and their storage conditions guarantee the quality and safety of allografts. Before the processing, highly qualified experts from the quality department and the medical director of the company carry out a three-level check of the donor tissues.

 

Data to be carefully checked and documented:

  • Assessment of donor eligibility

  • Medical and social history

  • Control of the donor's consent procedure for tissue donation for transplantation

  • Control of donation process, period of freezing and cooling, assessment of donation location, sequence of tissue donation

  • A record of the completion of tissue donation

  • Materials used in tissue donation, lot numbers and expiration dates

  • Evaluation of blood specimens

  • Infectious disease testing results

  • Preparation of tissues for microbiological testing

  • Exchange of information with other organizations involved in the tissue donation or receipt

  • Autopsy results (if any)

  • Tissue acceptance control: verification of transport parameters, verification of sent and received samples

  • Tissue processing records: compliance with tissue processing protocols, materials used, visual inspection of product and packaging, radiation sterilization parameters, permissible residual moisture values

  • Completion of quality analysis

  • Completion of technical inspection of products

  • Final labelling

Specialized characteristics of the center

  • Seamless floor made according to modern medical standards

  • Washable dense sealed ceilings

  • Airtight seams on the walls of one-piece sheet, glued with reinforced fiberglass polyester

  • Autonomous air filtration system

  • System of sensors for uninterrupted control of air purity and atmospheric pressure

  • Magnetic door interlock system for security and atmospheric pressure stability

  • Sterilization of materials and equipment with ethylene oxide and steam