Washing and Assembly of RTU packaging components for the pharmaceutical industry
Efficient solutions for the processing of sterile RTU primary packaging components
With our washing and assembly systems, we cover a large part of the process steps required for the production of pre-sterilized primary packaging components.
Whether it is the washing and depyrogenation of primary packaging, the application of various siliconization options, or the assembly of closure systems and crimp caps, groninger always provides the right system solution.
Processing steps for sterile primary packaging components
Ensuring reliable processing of sterile RTU components
There are different process steps involved in the production of ready-to-use syringes, vials or cartridges, from feeding the containers to washing and siliconizing to storing them in nests and tubs.
Feeding glass containers
When the prefillable glass containers are fed into the lines they are usually packed on trays. However, the exact packaging, varies depending on the primary packaging and requires a suitable system for feeding or handling.
Our systems takes care of your needs. groninger has several established solutions in its portfolio, from a detray module and a depalletizing module to state-of-the-art robot applications.
Washing
The glass containers are cleaned and dried in a washing module. On our lines, we reduced the media consumption to a minimum and are still able to achieve an excellent washing result up to a 3-log reduced cleaning.
Sterilizing/depyrogenation
The sterilization process developed by groninger places great emphasis on gentle processing, easy accessibility of all components for trouble-free maintenance, and, at the same time, the highest quality and process reliability.
Gentle sterilization is achieved in our innovative sterilization tunnel by means of IR preheating of the glass bottom in the inlet area. Quality is also ensured through the use of high-end sterilization filters.
A major advantage of this approach is the low temperature difference on the object. The desired germ reduction beyond overkill can be achieved with low stresses in the objects.
The modular design of the groninger tunnel makes it easy to assemble the number of heating and cooling modules that is appropriate for the process performance. We have developed a solution for the outlet of the sterile area that does not have a “ring of concern” and also does not require the critical inflatable seal.
Siliconization
Against the backdrop of increasing quality requirements and the increase in biotechnologically produced, protein-based drugs, an even coating of the surfaces of the glass containers with reduced amounts of silicone oil is necessary.
We have succeeded in minimizing the sprayed silicone oil amounts without affecting the sliding forces in our lines.
Checking
Control made easy: All lines or process steps can be equipped with different test systems. Sensors, state-of-the-art camera systems and complex X-ray systems can be integrated into the process.
These systems can be used to check geometric parameters and inspect glass containers for cosmetic defects. For example, groninger provides a camera system that checks the finger grip of a syringe for broken glass and the correct contour.
Assembly
One of the most important process steps of these lines is the assembly of various closures, needle guards and caps.
The closures have different properties and tasks. For syringes, the cannula must be protected from damage and kept sterile until the injection. There are also closures that are equipped with a needle protection mechanism, which is intended to protect against injuries on the one hand and prevent accidental reuse on the other.
In the system, all of these components are transported to the respective assembly stations via a specially developed storage and delivery system, where they are assembled on the glass container. Precise assembly of the closures is of the utmost importance.
All assembly processes are subsequently checked by a wide variety of inspection systems.
Tray loading
The processed and closed glass containers can then be used in a wide variety of pharmaceutical end packaging.
A gentle implementation is of great importance, here too the glass containers must not touch each other throughout the entire process. An inspection system can then verify that the final packaging has been completely filled.
Modular systems for processing RTU syringes, vials, and cartridges
Customized equipment concepts for different primary packaging components
Regardless of which pharmaceutical primary packaging components you manufacture for your portfolio, groninger provides a tailored processing and equipment concept for the washing, siliconization, and assembly of ready-to-use (RTU) packaging components. Our solutions ensure maximum process reliability and flexibility throughout the entire value chain.
Our systems can be flexibly configured to accommodate different primary packaging formats and production requirements. Even within a single packaging format, we can precisely implement and optimize your individual specifications.
Flexible solutions module for various closure systems
One example is our flexible assembly module, which can reliably assemble both needle and luer lock syringes with a wide range of closure components. Thanks to a minimal number of format parts, the module can be quickly configured for the desired closure systems and components. With decades of experience in processing pharmaceutical primary packaging components and in-depth expertise in their associated components, groninger is able to offer maximum precision in assembly while ensuring a high degree of flexibility within the overall equipment concept.
Modular equipment solutions: efficient, flexible, and GMP-compliant
Technical features and highlights of modern RTU manufacturing lines
- Washing: WFI (water for injection) is used to wash the glass containers. With decades of know-how gained on washing glass containers, groninger ensures that even the highest requirements in the pharmaceutical industry are met.
- Siliconizing: groninger uses its many years of development experience in the field of siliconization to create a homogeneous layer of silicon on the desired surfaces of the glass containers. Patented siliconization methods are used to manufacture sterile syringes and cartridges.
- Careful processing: To avoid glass breakage (and the resulting particles and contamination), the glass containers are processed and transported without contact. It is especially important that the glass containers cannot touch each other throughout the entire line.
- Laminar flow friendliness: The various line concepts and machine modules are designed in such a way that there is no movement above the glass containers. This prevents the possible turbulence of any particles that may be generated and ensures that the glass containers are always under First Air.
- Flexibility: Our lines provide you with maximum flexibility for processing a wide variety of objects and object sizes.
- Highest process reliability: Our systems for washing and assembling RTU syringes, vials and cartridges offer maximum process reliability through a wide variety of camera and inspection options.
