Quality Control during Manufacturing of Medical Products

In the area dealing with manufacturing of the medical products of prosthetic nature, the quality control is not just very important manufacturing task, but an integral part of the entire manufacturing culture, mode of thinking of engineering and work personnel. The manufacturing of medical purpose products simply cannot and shall not exist without the strictest and “clockwork” quality control.

The ABM Technology Medical Product Plant has undergone the strictest industry-specific inspections and holds all necessary Certificates confirming that we output exclusively high-quality medical products. Perhaps, the key credit on this count is due to a high-performance organization of the internal quality control.

At the Plant, the quality control is organized in multiple stages and in an integrated manner. Besides, acceptance and final inspections, the inspections for quality of works and production are carried out after each intermediate stage of medical product manufacturing. Organizationally, both the relevant specialists in the manufacturing areas and the employees of the Quality Control Department set up specially for this purpose take part in the quality control of our production.The package of quality control measures at the ABM Technology Medical Product Plant includes the following:

• instrumental verification (measurements) of their geometrical parameters;

• functional verificationofimplants and prosthetic components - structural tests, performance verification of assembled multicomponent products. 

 

 

 

Regardless of the fact that the machining is carried out on high-precision CNC machines reducing the role of human factor to a minimum, the hourly control of geometrical parameters of the parts being manufactured is organized and carried out in this manufacturing area. According to it, the products manufactured during the last hour form an intermediate lot. The Quality Inspector selects a single part from this intermediary lot, on which all necessary checks and measurements are carried out. If any signs of non-precision or improper operation of CNC machine are observed on the control part, the entire (hourly) lot will be rejected, and CNC machine will be subjected to check and setting. 

After the products are cleaned of contaminants got at the stage of machining (chippings, residual lubricant coolant), there comes one of the most critical stages in the quality control of our products wherein each manufactured product is being checked. At this stage, the Quality Inspectors carry out the following:

 

• instrumental verification in the course of which the following parameters are checked: accuracy of the geometrical parameters, surface roughness parameters, availability of mechanical damage (scratches, burrs, tears, and dimples);

• functional control in the course of which the accuracy of tolerances in the connections of multicomponent products and strength characteristics are checked (with the help of pressure equipment).

 

Quality control after abrasive machining (sandblasting) – the uniformity of machining and required parameters of its roughness are the parameters being checked..

 

Quality control after colour anodizing – the uniformity of painting and conformance of obtained colour to the standard specimen are the parameters being checked. 

This stage is of critical importance for our most mission-critical products– the implants on which the microporous surface (SLA or RBM) is being formed for their effective survival to a living bone tissue. The parameters being checked are as follows:

 

• uniformity of machining;

• characteristics of microporous survival surface.

 

The visual inspection is far from being sufficient for quality control of the microporous surface. At this stage, our Quality Inspectors actively use the microscopic techniques because the sizes of porous structure are measured by countable microns. 

When the next lot of implants is returned after radiation sterilization, all products are subjected to the visual inspection for the availability of external damage. Besides, some specimens are collected of this lot with a check of sterilization quality being carried out on them in our laboratory. 

When it seems that a medical product is completely manufactured, and it remains only to put it in a marketable package, the quality control of the ABM Technology Medical Product Plant is not ceased at this stage. The parameters being checked are as follows: 

 

After such integrated and multiple-stage quality control of the products being manufactured, you can safely assume that the medical products outputted by the ABM Technology Medical Product Plant do not have the slightest sign of reject. All products, which may have even the smallest deviations from the required parameters, are mandatory rejected in the course of a long chain of the numerous inspections and control. And this is our ultimate goal – to provide a Consumer with the highest-quality medical products.