Optimizing your Industrialization Process

For Medical Devices and Primary Packaging

In the Medtech and in the Primary Packaging industries, the industrialization process plays an essential role in the product development. However, the activities that are connected to this process step are often unconsciously neglected, just because most of its impacts are not visible for the short-term. In too many cases, the industrialization operations are consciously postponed to another time schedule (sometimes not even finalized) due to cost reduction or even worse, to accelerate the market introduction of a product! During the whole product lifecycle, wrong decisions that are taken at this critical step will influence negatively the market launch and the evolution of a product.

Main tasks of an Industrialization Process

• Turn a prototype to series-production readiness
• Supplier Evaluation
• Develop the technical documentation and meet the requirements of the targeted registration-country
• Implement a well-mastered and repeatable quality in the production process
• Train and coach the production staff
• Perform the added-value analysis in terms of productivity and cost-reduction in production
• Ensure the change control process

The industrialization in a stress field between handicraft work and a 100% controlled-process!

A high attention should be paid on regulatory Aspects

At the beginning of a product launch, the General Management and the Marketing Management are responsible to define where to register their new medical device. In association with all its responsibilities, the Industrialization Dpt. has to take care of regulatory requirements that are specific to each country.

Turn a Prototype to series-production readiness

• Qualification activities related to the “Equipment”:
  – Installation Qualification
  – Operation Qualification
  – Performance Qualification
• Validation activities related to the “Product”:
  – Product validation
  – Process validation
  – Cleaning validation
  – Transport validation
  – Sterilization validation
• Generate the technical documentation.
• Develop and implement the production process.
• Train the personnel for an optimized production process, including quality controls and SOP’s.

Evaluate and qualify Suppliers in strong Partnership with Quality Management

• Select suppliers from an approved supplier-sourcing.
• Support the qualification of new suppliers.
• Define specific defect catalogue together with QM.
• Support in defining the IPC related to the manufacturing process at the supplier.
• Helping the Quality Dpt. determining the content of the Certificate of Analysis.

Define and further develop Test Methods

• Define the incoming-tests for the production equipment.
• Evaluate test procedures and test equipment, if needed with the integration of external partners.
• Integrate test procedures and test equipment in the production process.

Perform the Analysis of the Added-value brought in Production

• Periodical analysis of the profit margin.
• Define the preventive and corrective actions further to the profit margin analysis.
• Controlling of the implemented CAPA.

Ensure the Change Control Process

• The industrialization leads and supervises all changes related to the serial
  production process.
• Update the technical documentation.

Challenges

A successful Head of Industrialization is able to address simultaneously technical, regulatory and human (pedagogics) challenges. Based on its experience, COPLAX Pharma’s Team is supporting Medical Device manufacturers and Primary Packaging companies implementing a successful Industrialization process. Do not hesitate and contact us at any time!