Schott Pharmaceutical Systems has 16 international facilities that are cutting-edge and manufacture approximately nine billion syringes, vials, ampoules and cartridges a year. It has more than 600 production lines using Fiolax glass to create the containers used for storing sensitive medicines. After hot forming using specialised machines, containers are heated in a temperature controlled oven and then cooled again. Throughout the process, there are regular checks to make sure the strict tolerance limits placed on pharma packaging are met. Finally, a Class ISO 8 or higher cleanroom environment is used for packing.
The creation of glass pharmaceutical packaging is a highly automated process, requiring the company to adopt an extremely organised approach. Large boards and electronic systems are used to record production workflows and events, while the working environment for employees and the guidelines for visitors resemble that of a cutting-edge pharma or food company rather than a traditional glass manufacturer.
Any contamination of the primary packaging could have direct consequences for the patient
It is precisely these industries that are the model for the Schott approach to quality. GMP aims to protect consumers and patients by bringing together quality guidelines on critical production processes. More and more countries are specifying GMP as a statutory requirement that suppliers of pharmaceuticals and quality-related components must meet.
Today, the importance of the primary packaging of medicines is widely acknowledged. Primary packaging is defined as ‘the container that is in direct contact with the drug’. Any contamination here could have direct consequences for the patient. This is particularly important if the containers are for injectable (liquid) drugs as the contents are administered directly into the patient’s bloodstream. It might sound dramatic, but any carelessness whatsoever in the manufacture of the packaging can potentially endanger human life.
High degree of trust
When patients take their medicine they trust that the manufacturer has created a product that is safe and meets high quality standards. Pharmaceutical manufacturers normally carry out the essential processing steps, such as cleaning and sterilising the primary packaging immediately before the containers are filled. However, it is up to the packaging manufacturer to deliver the containers in perfect condition.
Increasingly, containers are pre-sterilised and ready for filling without any preparation at the pharma company. Any product recalls due to faulty packaging would result in major financial and reputational repercussions for all companies involved.
The most common errors in the production of pharmaceutical packaging are product mix-ups, impurities and container closures failures. The latter results from barely visible gaps between stopper and container through which air or particles can enter and contaminate the product. Even the smallest of cracks in glass, caused by a faulty production process, can result in the container no longer being sterile. When a mix-up occurs, containers of different sizes or types may be delivered to the pharmacist in the same shipment, which can result in the patient receiving the wrong dose.
GMP guidelines aim to eliminate errors as far as possible and therefore compliance with GMP lies at the heart of the company's production processes. These are tested when Schott’s pharmaceutical customers undertake their regular audits to establish, for example, whether the company complies with cleanroom standards when it comes to producing sterile syringes.
But the real challenge for a production company is establishing a ‘GMP mind-set’ in all employees to ensure the guidelines are met every day. The company has therefore introduced a core idea of ‘100% responsibility’ to appeal to the sense of responsibility of each employee and to make each individual aware of their personal contribution.
Imagery designed by the company and placed throughout production facilities to remind employees of the core idea of ‘100% responsibility’ and to make each individual aware of their personal contribution
The key message that ‘Packaging is an integral part of the drug’ drives home the message that each person is not only responsible for the packaging but also for the safety of patients. This is particularly hard-hitting considering that with a production volume of nine billion units annually, it is very likely that each employee will know someone who will receive medicine packaged in a Schott container.
To back this up, the campaign deliberately uses emotional imagery to attract the attention of employees at various points in the production line. Everyone enjoys regular training courses to reinforce the strict guidelines and learn how, for example, the manufacturing of a glass tube relates to an injection and therefore to a person.
These ‘emotional’ messages are enhanced by an informative part of the campaign. For example, staff are reminded of the 10 key GMP rules on information boards:
- Take responsibility: Utmost care is required at all times
- Follow operating instructions
- Do what you were trained to do
- All procedures must be documented clearly, so that in an emergency when errors are discovered it is possible to limit the damage and to initiate targeted countermeasures
- Signatures must be readable so that it is possible to trace documentation back to the signatory
- Avoid contamination, for example by hair or fingerprints
- Do not mix products
- Abide by the four-eyes principle – all quality-critical process steps must be checked by at least two people independently
- Do not give approval without checking
- Promptly report deviations, so that corrective action can be taken immediately.
GMP requires that team members continually prompt each other, regardless of position, to adhere to guidelines. To lead the shift to this mind-set, senior management at all manufacturing sites carried out a whole day event to kick off the campaign. Personal presentations and company videos underpinned the message that everyone must work together to achieve compliance. A range of activities involving all team members also took place. Humour played its part too. For example, a light-hearted photo shoot demonstrated the correct application of cleanroom garments.
Schott has now rolled out the campaign across almost the whole company and has received positive feedback from the teams and customers in the process. Customers and suppliers who visit the facilities are immediately aware that compliance with GMP rules is a top priority. As a result, the campaign will not only have an effect internally, but will also enhance the image of the company as a trusted brand in the pharmaceutical industry.
Getting employees to sign up to the new quality ethos Imagery designed by the company and placed throughout production facilities to remind employees of the core idea of ‘100% responsibility’ and to make each individual aware of their personal contribution