Tlm technology wins the customer over

Project management including all preparation and related services
Development of new separation technology for the BFS blocks
Development of new packaging material
Development of sterilisation trays
Line management system with integrated track-and-trace functionality
Compact design
High line efficiency

Requirements

Consulting, project management and technology from a single source

Packaging lines for a new product: Schubert-Pharma supplies Nephron with two packaging lines for packing BFS vials and provides line handling for secondary packaging as a supplier and service provider.

Nephron, a leading manufacturer of generic respiratory medication and a pharmaceutical contract manufacturer, was on the lookout for a suitable supplier and service provider for the secondary packaging of a new product at its production site in South Carolina, US. Schubert-Pharma has developed an innovative packing process for polypropylene vials filled with injection agents.

Solution

Assembled from the TLM modular system

Nephron were planning to pack a new product at their new production site: an injection agent in a new type of vial, made for the first time from polypropylene instead of polyethylene. Nephron had no previous experience with handling this product in a secondary packing system. The products also needed to be sterilised in an autoclave – another unfamiliar step in the process for the company. Furthermore, the products would need to be fitted into a shrink-wrap sleeve before being packed into cartons, instead of being identified using a labelled bag or a separate label like other Nephron products.

A comprehensive consulting service

These requirements meant that Nephron’s chosen partner had to have expertise in consulting and project management. Schubert-Pharma quickly proved to be the ideal partner for Nephron in developing the line’s new functionalities. In addition, Schubert-Pharma advised Nephron on the implementation of each step in the process. The specialist team supplied Nephron with two packaging lines, each comprising four individual machines: a tray loader, a product splitter, a cartoner and a case packer. All the functional elements are based on the TLM modular system – yet more evidence of its enormous potential.

The products were new to us, as were some of the process steps, such as sterilisation, so we were on the lookout for an expert to guide us through the entire process and to help us select individual tools. Schubert-Pharma took on this role brilliantly. The main reason why we chose Schubert-Pharma was that we would be able to design the entire secondary packaging process using the TLM modular system’s seven basic components, which had already proven themselves in several other projects.

Jonathan Burgess

R&D Engineer at Nephron Pharmaceuticals in Orlando, US

Technical Details

2 packaging lines with 4 individual machines

TLM tray loader

In the first machine, the blow-fill-seal (BFS) blocks are taken from the primary machine and sorted into sterilisation trays. The trays are fed by a P4 depalletising/P4 palletising robot. The products are handled by F4 pick-and-place robots. These robots offer the advantages of being able to deal with future product sizes without the need for complicated size adjustments. The completed product pallets are automatically prepared for the next step in the process: autoclaving.

TLM product splitter

After autoclaving, the second step is to depalletise the sterilisation trays and prepare them for product removal. The BFS blocks are taken out of the trays row by row and placed directly into the separating station. The separator tool separates the vials from the blocks using a shearing motion that is designed for careful product handling. This removes the danger of tearing a vial during the separation process. A second F2 robot takes the separated products as they come out of the separating station.

Besides the careful separation process, what is special about this stage of the process is that the products are placed headfirst in product carriers, known as PUKs. The "empty status" of the trays is checked using sensors, and the trays are palletised for reuse. A complete autoclave batch can be handled in the pallet infeed and discharge preparation zone.

In two downstream intermediate steps, the products are seals are checked (vacuum check) and then fitted with a shrink-wrap sleeve.

TLM cartoner

The top-load cartoner is the ideal solution for cartoning "standing" vials with different vial heights and different numbers of vials in the cartons.

The cartoner’s product handling is particularly noteworthy: in a "handshake" process, the products are removed from the product carriers and passed on to a second TLM F2 robot. During this transfer step, the products are swivelled 180 degrees, allowing them to be passed to the loading robot in the desired orientation. The loading robot spreads the product row out into the desired number of vials per row in the carton. Before the product carton is closed in the cartoner, a package leaflet is placed inside. The finished cartons are transferred to the downstream case packer.

TLM case packer

In the final TLM machine, the product boxes are placed inside a FEFCO shipping carton. The case packer is able to carry out all standard carton sealing methods that conform to the FEFCO standard, from AFM cartons to gluing or tape closures (with an extension). An interesting detail is the integrated label dispenser, with the option of around-the-corner application. Finally, the completed shipping carton leaves the packaging line and moves on to central palletisation and goods logistics.

LMS and track-and-trace system

Schubert-Pharma has designed and supplied an intelligent line management system (LMS) with integrated track-and-trace functionality for the entire line. This allows all batch data to be administered and linked to coding on the product trays. The batch data is administered in the packaging process and assigned to the individual orders. The system receives the relevant (randomised) serial data for the product boxes from a higher-level data control system, aggregates this data for each shipping carton and transmits it back to the MES system at the production site.

Overall Performance

2 packaging lines each with 4 individual machines: tray loader, product splitter, cartoner and case packer
530 vials per minute per line: 9 million vials per machine per month
Sterilisation in an autoclave
Shrink-wrap sleeve before packing into cartons

F4 robots load the trays.

The F4 pick-and-place robots handle the products in such a way that they can deal with future product sizes without the need for complicated size adjustments.