Schwarz Pharma, Germany

Schwarz Pharma AG is a German-based pharmaceutical company involved in bulk manufacturing, packaging and also the material management of pharmaceutical drugs. The company specialises in manufacturing solid oral dosage forms and packaging with modern blister machines and also provides raw material and packaging materials for the pharmaceutical industry. The company’s main areas of interest are cardiovascular (CV) disease, gastrointestinal tract (GI) diseases, urology and central nervous system (CNS) diseases. Schwarz has facilities in the UK, the US, Germany, Italy, Switzerland, China, Hong Kong and the Philippines.

Healthcare packaging

In February 2007 Schwarz Pharma undertook the installation of a new high-speed packaging line at its Seymour, Indiana facility in the US (operates on two shifts five days a week). The new line required an investment of around $3m and was completed in six weeks followed by a three-week period of testing and commissioning (staffing has been reduced from nine to seven and the new line is achieving its goals running at 80% of capacity).

The line was installed to replace an older slower line (20 bottles per minute) for the filling of four litre (1 US gallon) polyethylene asymmetric bottles with an off-set neck containing PEG oral solution powders (salts for GI flushing) for hospital use. The new line can now fill and process 40 bottles per minute and has also introduced a better containment system to reduce product wastage and improve safety.

The containment/enclosure system for the new system also speeds up changeovers because there is less powder lost and hence, less clean-up to be carried out. The new line can also handle new bottle formats being configurable for a new 2 litre bottle size and also 16 and 24 ounce symmetric bottles (the bottles are recycled). The entire line was replaced from ingress to egress including: bottle descrambler, bottle cleaner, two-stage filling systems, capper, induction sealer, labeller, and case packer. NJM/CLI was responsible for the line integration and setting up.

Process

The bottles are first oriented using a Pace Packaging bulk hopper and also an Omni-line M500 unscrambler. The system uses a feed hopper of around 165ft³ which is filled by hand and can hold around 125 bottles at once. The bottles are then oriented onto a conveyor and transferred to the next station, which is a 14-station orbit rotary cleaner supplied by McBrady Engineering.

This system picks up and inverts the bottles before blowing air into them to flush out any particles and then draws on them with vacuum and places them back into the line. The bottles then enter the contained filling room which has two All-Fill systems for the 4 and 2 litre bottles. Filling is carried out in two stages for the larger bottles (2 and 4 l) and a single stage for the smaller bottles. The initial filler is an All-Fill Multi-Fill Series 70 linear filler equipped with four auger filling stations and also an enclosure. After the first filler continuous flow filling a pick and place system takes four bottles at a time and spaces them for indexed filling on the first system and then continuous flow on the second (multi-component filling according to a controlled formulated recipe). The filling augers are controlled by a feedback loop for precision (controlled by check-weighing after the filling because active ingredients must be down to 0.2% accuracy). The bottles are then transferred to a parallel counter-current conveyor and around to an All-Fill 12-station, continuous-motion rotary filler with enclosure.

Following this the bottles move to be check-weighed and for metal detection by an All-Fill Alpha checkweigher (this communicates with the filling machines to adjust to the correct amounts). There is then a reject station to remove out of specification products (OOS). The filled polyethylene bottles are then transferred to be capped using a Kaps-All six-head/three-station capper, which is particularly good at handling off-set bottle necks without damaging the rest of the bottle.

There is then an optical inspection system to determine if the cap is on the bottle correctly (provided by NJM/CLI). The bottles are then passed to an air cooled induction sealer provided by Enercon Industries Corp (handles 20% of line output), which is adjustable for different height bottles and also has an easy adjusting all-in one pivoting head to change the dwell time for different size closures. The bottles then exit the filling area completely and are transferred to be unscrambled and labelled using an Auto-Colt Model 326 print-and-apply labeller supplied by NJM/CLI (servo driven label dispenser with programmable logic control). This labeller puts labels on the bottle bearing information including: product name, product code, lot, expiration date, and NDC number.

Prior to label attachment the printed label is bar code inspected by an optical system supplied by Optel Vision to verify the Code 128 bar code and the associated information. Once the label is applied there are also two more optical inspection devices to examine the label as required by FDA guidelines (checks if the label is on straight and if it is correct). The bottles then pass to the warehouse and are collated by a robot IMA top-loading case packer that compiles bottles either six or 12 to a case.