The Motek in Stuttgart (international trade fair for production and assembly automation) has closed the doors - time for a little summary.
OCTUM GmbH, Renntalstraße 16, 74360 Ilsfeld, Germany
Safety is the top priority in the pharmaceutical industry, since production errors and process errors, counterfeit products or confusion can have deadly consequences. On the high speed production lines of the pharmaceutical industry, defective components can lead to downtimes and productivity losses. The earlier production errors are identified and eliminated, the more economical the process of doing so.
The pharmaceutical industry uses vials as containers for solid and liquid products. A rubber stopper allows piercing with a syringe needle and therefore the sterile removal of fluid. In the processing lines the vials are sterilized, filled and sealed using the stopper and the additional alu cap. The alu cap is crimped around the upper edge of the vial in order to press on the plug at a defined force, ensuring maximum watertightness. The crimped cap is sealed using a lid, which is broken off before use to give free access for piercing. A visible or invisible code is marked on the cap for automatic vial identification. A label with fixed and variable data is then affixed to the vial and is used for automatic and manual identification of vials and active ingredients. The processes run at cycle times of up to 40,000+ items/h.
The following inspections are carried out during these processes
The compact, application-specific design and standard interfaces enable inspection systems to be integrated into existing production lines. Where several systems are integrated into a single line, the operator benefits from the uniform appearance and central, unified operating and visualization concept with OCTUMISEr.
The empty glass inspection ensures that before being filled with expensive pharmaceuticals, vials have no impurities such as glass fragments, splinters, debris and cracks. The inspection can be integrated into the filling line or into an isolator. Depending on formats and customer requirements, one or more inspection stations are used, usually with several cameras.
Integration can be done in the linear conveyor or on a circular path in the transport star. In changeover format, only the camera positions are normally tracked.
According to the minimal defect size specification and format sizes to be inspected, camera selection is also application-specific. The in-line empty glass inspection increases productivity and boosts operating efficiency by rejecting vials with impurities and defects before filling.
The filling level is usually checked after the vials have been filled with solid or liquid pharmaceuticals. With suitable formats, this inspection can be run simultaneously with the stopper gap inspection. For low-transparency plastic vials, an individual inspection station is required
Depending on pharmaceuticals, conveying speeds and distance to the filling station, blistering can complicate level detection, or can at least adversely affect accuracy. The Octum systems are also designed to minimize these effects. Depending on the container shape, the level inspection is often combined with other assembly and dimensional inspections of the vials (e.g. type, position, angle, cap height, pipette height, etc.). This requires several cameras in a inspection station or, if necessary, separate inspection stations. The system design is, as appropriate, application-specific based on smart cameras, or PC-based with selectable camera resolution.
The level inspection ensures that only correctly filled vials continue in the process chain and reach the market and also permits immediate countermeasures to be taken in case of filling problems, thereby increasing output.
In accordance with GMP, Appendix 1, when filling vials with pharmaceutical products, the stopper fit must be checked using a suitable inspection system before the crimped cap is fitted in order to minimize microbiological contamination.
Owing to dimensional tolerances on vials and stoppers, as well as to position tolerances and conveyor system vibrations, straightforward height measuring systems have proved to be unsuitable.
In order to perform inspections that are not influenced by these effects, the gap width between the bottom edge of the stopper and the top of the vial must be measured.
The pharmaceutical industry normally allows a maximum gap of 1 mm, measured at conveying speeds of 40 m/min. Moreover, in this condition, the vial is still considered to be unsealed and is located in the insulator.
The Octum image processing system for stopper fit inspection meets all customer requirements. It is inspected using two cameras, which are arranged at an angle of 90° to each other. The stopper gap is measured at four locations at an accuracy of ±0.05 mm or better. The cameras are housed in an insulator-capable stainless steel housing together with the required deflection mirrors and the LED lighting. This space-saving layout permits the system to be ideally integrated into the filling line. This applies to vials in the linear conveying direction as well as to circular path movement in the transport star.
Reliable defect detection and the compact design as well as the insulator capability of the stainless steel housing ensure easy integration into any machine and line.
The following defects are checked during crimped cap inspection:
Because incorrectly sealed vials may lead to the contamination of products, the integration of an optical inspection system into the processing machine is mandatory.
The custom design of the sensor head offers both vial processing machine manufacturers and end customers optimum integration of the optical inspection system. The customized sensor head with three cameras and a mirror layout is used for inspecting the overall crimping and the caps.
Black and white or color cameras are used according to customer requirements. The sensor head is also available in an insulator-capable stainless steel design. The camera resolution is set according to the specific defect specification and format geometry.
Octum delivers a specifically adapted image processing system for the inspection of crimped caps on vials and ensures reliable defect detection in accordance with pharmaceutical industry standards.
The unique identifier and secure identification of the identifier of individual products on the vials, folding box, bundle, dispatch box and pallet provides the prerequisite for product traceability throughout the logistics chain.
Different statutory rules and international regulations for the identification and serialization of pharmaceutical products require flexible detection systems for these different marking methods. Octum systems for the secure identification of pharmaceutical products have proven themselves for many years with manufacturers and end customers as a component of flexible track & trace solutions.
Octum ID systems read and verify all fixed and variable printed characters of pharmaceutical products as a direct marking or on the product label.
The systems are equipped with fast, secure OCR/OCV and code reading functions for 1D and 2D codes, such as the Pharmacode or the Data Matrix Code (DMC), also according to the GS1 standard. The data is read in both the visible and the non-visible range, e.g. UV.
The reading stations can be used at any point in the packaging line and, as well as the straightforward reading functionality, can also handle the inspection of symbols and safety symbols, label position control and other quality tests on products and packaging units
Typical variable data that are read and inspected on labels and products are:
Image: OCTUMISEr interface
Typical non-variable print symbols that are checked for completeness of the print image are, for example:
Sample label with bar code and plain text
The individual stations are custom designed and are implemented with either systems based on smart cameras or PC-based systems with linescan or matrix cameras. The OCTUMISEr system software, which is also available as a 21 CFR Part 11 version, handles the central operation and visualization of up to 99 networked smart cameras. The easy, clear operation gives users access to system observation only, format preselection, new symbol and character set learning or the full creation of new formats, depending on user access rights. The PC-based CV-600 systems with the CV_Inspect system software are also available as a 21 CFR Part 11 variant.
Octum ID systems quickly and reliably provide the data that is necessary for complete product documentation and traceability from the individual packaging to the pallet. The system flexibility and easy extensibility of functionality mean a future-proof investment for our customers and a contribution to improved safety for patients.
The vials are packed in boxes, or are first packed in cartons, then in outer packaging, for further transport. It must be ensured that the number of packaged vials or boxes is correct. With multi-layer packaging, the correct insertion of individual cartons (correct packing patterns) must also be checked in order to prevent packing errors and costly machine downtime.
Where contrasting patterns or codes are present on boxes, packing patterns can be detected with 2D cameras. If no optically contrasting features (printing, pattern, logo, etc.) are visible on the boxes and pallets and if no top view is possible with the machine being used, Octum uses 3D TOF cameras for reliable detection. This system allows several packing levels to be inspected from a fixed camera position without camera tracking. System calibration is not required – the corresponding level can also be tracked automatically in the x and y directions using the 3D distance values.
Detection takes place regardless of color, even in very tight packing patterns without visible separation between the individual packages. Even tilted and geometrically incorrect packaging is detected reliably.
The combination of 2D solutions with 3D packing pattern detection is a very flexible and advanced track & trace system solution.
Octum systems ensure that only complete and properly packaged products enter circulation. The system flexibility and easy extensibility of functionality guarantees a future-proof investment for our customers.