G_Great
P_Performance
E_Engineering
Full-service supplier for a high-quality inhalation aid for the treatment of asthma in infants and toddlers up to 6 years of age.
Stable manufacturing processes developed, stringent quality standards met, products delivered ready for sale.
One-of-a-kind development and manufacturing expertise in plastic and liquid silicone components.
Spacer for metered-dose inhalers used in the treatment of asthma
BREATHE IN, BREATHE OUT, BREATHE OUT. FOR INFANT, TODDLER, PARENTS AND CUSTOMERS
Effective asthma treatment for infants and toddlers up to six years of age thanks to ‘Great Performance Engineering’ – the spacer, an important inhalation aid, creates the necessary minimum distance and thus enables the formation of an aerosol cloud suitable for children.
The task
CMO supplier for complete production. GPE was engaged as a contract manufacturing organisation and tasked with the development of new tool concepts, production and country-specific, saleable final packaging, including logistics services.
The challenges
The customer was looking for advice on an optimum production concept and the best technological solution using plastic injection moulding. Its focus was on a component design optimised for injection moulded plastic, taking into account the technical requirements and specifications, including mould concepts.
The customer was looking for the entire vertical range of manufacture, from the raw materials to be used, the production of the plastic and liquid silicone components, assembly under clean room conditions to country-specific consumer packaging. The basis for realising the project were the customer’s design and production specifications as well as the supplier management for purchased parts.
The customer was looking for the entire vertical range of manufacture, from the raw materials to be used, the production of the plastic and liquid silicone components, assembly under clean room conditions to country-specific consumer packaging. The basis for realising the project were the customer’s design and production specifications as well as the supplier management for purchased parts.
The solution
GPE developed a smart manufacturing concept for the seven individual parts of the later assembly according to customer specifications, and optimised various individual components agreed with the customer to ensure that mass production ran smoothly. GPE developed new mould concepts and planned the production of the liquid silicone masks and the associated automation. Assembly was performed in a class 8 clean room in accordance with DIN EN ISO 14644-1, whereby the assembly of the individual parts met stringent quality requirements with respect to appearance and tolerances. Quality control also included testing the flow rate of the assembly.
As the process progressed, GPE integrated itself into the customer’s existing supply chain and assumed responsibility of the complex process of managing the suppliers of purchased parts (secondary parts) including packaging materials; this also included certified suppliers specified by the customer. GPE handled the complete quality documentation (DIN-ISO documentation) of the final product – from the raw material to the country-specific labelling (MDR-compliant). This enables the batch traceability of all components back to the raw material used.
As the process progressed, GPE integrated itself into the customer’s existing supply chain and assumed responsibility of the complex process of managing the suppliers of purchased parts (secondary parts) including packaging materials; this also included certified suppliers specified by the customer. GPE handled the complete quality documentation (DIN-ISO documentation) of the final product – from the raw material to the country-specific labelling (MDR-compliant). This enables the batch traceability of all components back to the raw material used.
The added value
In close collaboration with the customer, GPE developed and defined well-engineered and stable manufacturing processes. GPE is responsible for managing the suppliers of purchased parts, including smart scheduling, and is responsible for delivering the respective saleable packaged final products to the customer’s central warehouses in over 50 countries. In short, GPE acts as a full-service supplier and tier one supplier, handling manufacturing, production and logistics. All the customer has to do is order from GPE.
The application
In the effective treatment of asthma in infants and young children up to six years of age, the aerosol cloud generated plays a critical role. This cloud can only form correctly if a minimum distance of 23 cm is maintained and a minimum volume of 300 to 500 ml is available. However, infants and young children with a breath volume of 6 to 14 ml/kg must be able to inhale the suspended aerosol cloud with 5 to 10 breaths within 8 to 10 seconds. This is guaranteed by the design of this inhalation aid, whereas with current products, more of the asthma medicine is consumed per use because much of the medication cannot form into an aerosol cloud.