Aseptic processing of eye drops and nasal spray
Eye drops are used for a wide variety of medical applications, from simple eye moistening to local anesthesia. Compared to most pharmaceutical products, the profit margins are often lower. This makes it important to be able to guarantee efficient and cost-effective processing for both pharmacy-only products and the over-the-counter (OTC) sector.
groninger lines provide the highest level of flexibility. Whether small batches or large batches, whether for product development and clinical studies or for commercial production, our lines have a performance range of 50 to 400 units per minute (3,000 - 24,000 units per hour).
At the same time, the groninger line can be adapted quickly and flexibly – a key criterion, especially for CMOs and CDMOs. These lines for filling and closing eye drop and nasal spray bottles are usually equipped with our innovative Quickconnect technology. This enables a tool-free format change via the HMI. Our transport line which can process different objects, also ensures a smooth changeover.
Sorting & feeding
Our sorting lines allow effective sorting of a wide variety of round and oval objects. Permanently correct sorting is essential for the efficiency of the lines.
The groninger lines also make it easy, safe and completely sterilizable to feed all objects into the respective containment – whether oRABS or isolator. The use of gamma or ETO-sterilized primary packaging for eye drops is now common practice.
The filling process is the heart of our system. For this we use different technologies to be able to process a variety of thin to viscous products. Whether water-like/WFI-based products or solutions, we have the right system.
When filling liquids, groninger relies on proven filling technologies such as the rotary piston pump and mass flow filling systems. Each of these filling lines can be used for one or more types of product.
Within these filling lines a wide variety of product-related tasks can definitely also be performed in the filling path. In particular, a clean-in-place/sterilize-in-place (CIP/SIP) module can be installed prior to filling.
Whatever you need, groninger adapts the filling processes to the needs of your product so that you do not have to compromise on quality.
To meet the high requirements of the pharmaceutical industry, we are increasingly replacing Statistical In-Process-Control (IPC) with 100% In-Process-Control (IPC) as the standard. To do this, the containers are weighed individually both before and after filling to be able to check the filled content with the highest degree of accuracy. This process step is one of a large number of quality assurance measures that we provide.
When closing the products, precision and quality have top priority preventing particles from getting into the product. Here we meet the latest FDA Annex 1 requirements.
The groninger Quickconnect technology was developed to ensure an aseptic closing process. This is characterized by the simplest set-up of the sterilized format parts. The number of closure size-dependent sorting and feeding formats has been optimally minimized to ensure maximum flexibility.
To provide you with security against the independent inspections of your fillilng line, the groninger sorting and feeding technology is constantly being further developed, while the focus is always on an optimal laminar flow.
User-friendliness is central to the ergonomics of our lines. This allows that all parts are always easily accessible with gloves.
We counter the trend towards more sensitive and also more expensive products by integrating a gassing station for the so-called 'headspace' in the container to achieve a residual oxygen content of less than 5%.
Another trend is the production of preservative-free products, which requires a new type of closure system to ensure that products remain stable after opening. groninger also has the correct solution for this application.
In the closing area, accurate screwing is one of the major challenges, particularly, when it comes to soft plastic bottles. For many users of eye drops, for example, it can become a major problem if the vials are screwed on incorrectly or too tightly.
The groninger tightening technology provides an efficient and economical solution for extremely accurate tightening, which also includes a monitoring step in which incorrectly tightened objects are detected and rejected.
We also have the right machine constellation for other closures for nasal applications with and without a dip tube; the same goes for push-on filter caps for preservative-free eye drops.
At the end of the process chain, the individual objects are collected in a tray for storage and covered, if necessary. With our very object-friendly pick & place system, groninger provides easy-to-use solutions for storing objects piece by piece on a tray. This process is usually implemented fully automatically.
Do you have any other questions?
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