How to make packaging and serialisation of pharmaceuticals flexible and efficient

THE CHALLENGE

The pharmaceutical manufacturer Hormosan was looking for a new solution in the field of manufacturing pharmaceutical packaging in time for the start of the serialisation regulations in force since 9 February 2019. Specifically, it was about taking over secondary packaging and serialisation for small markets or highly fluctuating volumes. Hormosan wanted to continue to run the bulk of the production and packaging through its contract manufacturers. The reason behind the search for a new solution was that up to now the smaller outer packaging and packaging orders had been carried out at the company’s own premises. Due to the increased requirements, when the company moved to a new site, it was decided not to invest in production capacity there anymore. Rather, the smaller manufacturing orders were to be outsourced to a specialised service provider. The main focus was on a solution for packaging and serialisation, but also on the exchange of package leaflets or the repackaging of broken goods. Basically, the service provider should also be able to process semi-finished goods, i.e. blistered goods without folding boxes and package leaflets.

THE SOLUTION

“We explored the market at an early stage and checked which partners would be suitable”, explains Christian Schumann, head of the supply chain at Hormosan. “In discussions with trans-o-flex, we learned that trans-o-flex Logistik-Service is also planning a production area and serialisation.”

Why Hormosan opted for trans-o-flex
Schumann explains his decision in favour of trans-o-flex as follows. “Both companies have been working together successfully for years. trans-o-flex has been storing and consigning pharmaceuticals for Hormosan since 2001. This means an extended service can also be provided from a single source and at the same site. This has several advantages: thanks to the short distances for retrieval from the warehouse, repacking and return to the warehouse, we speed up processes and minimise risks, such as transport damage. Overall, we will also be much more flexible, The warehouse knows the exact stock, knows what you can take, and processes are not disrupted.”

Manufacturer’s licence according to national and European law
The prerequisite for trans-o-flex to accept the Hormosan orders was a manufacturer’s licence for the packaging of pharmaceuticals in accordance with German and European law, section 13 of the German Medicinal Products Act (MPA) and Good Manufacturing Practice (GMP). In almost two years of meticulous preparatory work, the company created these conditions. In summer 2017, the GMP production facilities construction project was launched, in September 2019 the Upper Franconia Regional Council inspected and accepted the project and in November the licence was granted. For the company, this step constitutes a strategic expansion that is important for two reasons. 1. Only with this expertise and the associated additional possibilities will it be possible to continue to operate the traditional core business effectively in the future. 2. In future, efficient warehouse logistics solutions for pharmaceuticals can only be offered by those service providers who, firstly, are licensed to repackage or pack pharmaceuticals and, secondly, also meet the requirements for serialisation that have been in force since February 2019.

Solution makes customers more efficient and flexible
Hormosan is not the only customer interested in this expertise. “Smaller customers in particular are increasingly asking whether we offer not only classic warehouse logistics with and without temperature control for their finished pharmaceuticals, but also repackaging or secondary packaging”, says trans-o-flex Logistik-Service. “This distribution of tasks makes our customers both more efficient and more flexible.” Companies can then, for example, have a pharmaceutical product produced only in one packaging size or as a semi-finished product. “Should there be a need for additional prescription sizes, we can meet the demand on an order basis.” The same applies to sales expansions, for example, if a pharmaceutical is also to be marketed in other countries. “We can then take the goods from the existing stock, repack and ship them.”

Counterfeit protection thanks to serialisation and tamper-evident closure
In order to be able to offer this service on a permanent basis, trans-o-flex also meets the requirements of the Counterfeit Protection Directive 2011/62/EU and the Delegated Regulation (EU) no. 2016/161. On the basis of these, a system for verifying the authenticity of medicines has been established within the EU to protect patients from counterfeit medicines in the legal supply chain. Each package of prescription medicines is therefore provided with additional security features. They ensure the authenticity (tamper-evident safety seal) and allow the identification of each individual package (individual serial number). All the manufacturing processes are supervised by a pharmacist.

About Hormosan
Founded in 1968 in Frankfurt am Main, Hormosan Pharma has been part of the internationally active Lupin Group since 2008. As part of this affiliation, Hormosan Pharma has developed into a specialist for high-quality niche products, original drugs and generics with a unique character in the core areas of central nervous system (CNS), pain, HIV and gynaecology. Special emphasis is also placed on rare neuromuscular diseases such as myasthenia and ALS.