The medicine of the ancient Egypt is one of the oldest documented and was highly advanced for its time, including simple non-invasive surgery, setting of bones and an extensive set of pharmacopoeia. Medical knowledge in ancient Egypt had an excellent reputation, and rulers of other empires would ask the Egyptian pharaoh to send them their best physician to treat their loved ones. Since that time, medicine has evolved dramatically—even incorporating Eastern medicine traditions, but Swiss pharmaceutical company Novartis has been producing and filling a range of pharmaceuticals from Egypt for more than 50 years. The company’s product portfolio includes solids, liquids, semi-solids, and sterile products.
Headquartered in Basel, Switzerland, Novartis is one of the largest pharmaceutical manufacturers worldwide with 129,000 employees in more than 140 countries. The company’s top-selling brands include Glivec to treat certain types of leukemia, Diovan to treat high blood pressure and heart failure, and Lucentis to treat eye maladies such as wet age-related macular degeneration, macular edema caused by a blocked blood vessel in the eye, and diabetic macular edema.
The Novartis plant in Cairo, Egypt covers an area of 80,000 sq m and produces enough medication to meet 7% of the country´s market needs. Originally, the plant was established in 1962 by Ciba-Geigy & Sandoz and Wander under the name “SWISSPHARMA” to produce a volume of 1.6 million units/yr. Under Novartis, the plant now serves as a base for the manufacturing and supply chain management of prescription pharmaceuticals, as well as over-the-counter (OTC) products.
Following the merger, output rose to 122 million units/yr of more than 100 different products. The Cairo facility meets the highest Health, Safety and Environment (HSE) standards, complying with ISO 14001 and OHSAS 18001, as well as receiving Novartis’ own internal HSE award 12 years in a row. In 2006, the plant saw a US$16 million overhaul vastly enhancing its infrastructure, technology, efficiency, and capacity.
Three in one
However, the facility met its match trying to fill and package 15 mL plastic bottles of Otrivin Saline Baby nose drops, 10-mL plastic bottles of Otrivin nasal spray and 100-mL glass bottles of Catafly Suspension cough syrup. Each product has a different packaging format, threatening the strides made in efficiency and output.
To meet the demand for these products, Novartis needed to invest in equipment flexible enough to accommodate the different products and packaging formats.
As a result, Novartis enlisted Bosch Packaging Technology, a provider of packaging solutions for the pharmaceutical industry. The objective was clear: create a single equipment solution that could fill and package all three products. Varying consistencies presented one hurdle. While the nose spray and drops are oily, the cough syrup is stickier.
The different packaging formats presented as much of a challenge—particularly since these require different types of closures. While a screw cap, insert, and measuring cup are necessary for the cough syrup, an insert and screw cap for nasal drops and spray pump with screw cap are needed for nasal spray.
Novartis needed equipment that would be highly flexible and easy-to-clean during changeovers between products. The solution also had to consistently fill each bottle with the exact same amount of liquid every time.
“Bosch is a leading provider of packaging solutions for the pharmaceutical industry,” says Mohamed Galal, Project Manager at Novartis in Egypt. “We were impressed by the flexibility of the company’s equipment from a technical perspective and confident that Bosch had the capabilities to produce a single-line solution for these three products.”
Lean and clean
Bosch’s team set to work, producing a customized line that met Novartis’ criteria, starting with a bottle unscrambler, followed by an air blower to clean inside all three bottles and prevent particle contamination. To clean the plastic bottles, each blowing nozzle ionizes the blowing air, which neutralizes the electrostatic loads on the inner surface of the bottles and facilitates easy foreign particle removal.
Because this function is not needed for glass bottles, it can be switched off easily during production. The bottles then move into a linear piston-filling machine equipped with 10 nitrogen pre-flushing nozzles and 10 fill nozzles. Nitrogen flushing reduces the oxygen content in pharmaceutical products to prevent oxidation after capping.
To allow for format flexibility, the line incorporates three different rotary capping machines, which are used depending on the product. The first is designed to equip each nose spray bottle with a pump. The second rotary capping machine applies the plug to the nose drop bottles. The third capper is used for all formats: screwing of all three different caps on each bottle and placing the measuring cap on the 100-mL glass bottle.
A key function of the line is the Cleaning-in-Place (CIP) Plus-system, which ensures repeatable cleaning results. The system is designed to clean all product-contact parts without requiring machine disassembly. Cleaning must be done after every product changeover. From filling to capping, the line is fully covered by a laminar flow hood that leverages overpressure to prevent any intrusion of foreign particles.
From capping to labeling
After the capping process the bottles are conveyed to the labeling system, with the exception of the preprinted nasal spray bottles. For secondary packaging, the bottles are fed into the continuous-motion cartoning machine CUK from Bosch, which fulfills Novartis requirements in format flexibility, short changeover times, and less maintenance. Novartis runs a total of 15 different format options for product, cartons, and leaflets sizes, which the Bosch CUK can easily set in a short time.
The cartoner´s “swing-open” leaflet feeder allows for the operator to quickly ensure that leaflets are correctly in place without a second person helping from the back of the machine. Feeding of leaflets and carton blanks are located closely to one another, further simplifying the operator’s work.
All cartons are positively opened by a “counter” suction head that forms the flat cartons into three-dimensional shapes and eliminates “dead” cartons that failed to unfold. This results in the safe handling of critical carton qualities, no material or product loss, and decreased production downtime. In addition, all leaflets are carried in mechanical grippers that reliably place them into the cartons. These are only some of the functions that reduce machine stops to a minimum, contributing to higher uptime.
Flexibility, speed and energy efficiency yield results
Not only did Bosch’s customized system for Novartis help the company streamline the filling and packaging of three different products with different packaging formats, it also enhanced production speed from a rate of 100 bottles/min to 140 bottles/min for sizes of 10 mL and 15 mL. For 100-mL bottles, speed increased to 120 bottles/min. The equipment also improved energy savings by US$60,000 annually with its advances to the bottle cleaning process.
Bosch’s line further enhanced the Novartis’ Good Manufacturing Practice (GMP) and HSE compliance for the liquid lines’ work center. The company also acknowledged qualitative improvements to the supply flexibility when greater quantities are requested, ensuring business continuity. “Bosch provided agile service and support through every phase of the project,” said Galal. “The results speak for themselves and we anticipate a long-term partnership as we grow our business in Egypt and beyond.”