Single –Use Systems for Flexible Operations in Biopharmaceutical Production

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

Logistical Challenges with Single–Use Bioreactors

The trend towards implementing single-use products poses not only new technical, but also logistical challenges concerning the security of supply and supply chain management (SCM) issues. This applies both to manufacturers and users of single-use products. In an early phase of technical development, as can be currently observed in biotech processes, single-use products are undergoing continuous and fast-paced development and innovation. This gives rise to recurrent changes primarily with respect to the following:

• Materials, material compositions

• Single-use components, sensors, connectors, etc.

Complexity concerning the configuration of single-use products Such recurrent changes also lead to new challenges of a logistical nature to which the manufacturer must respond quickly and efficiently by:

• Changing manufacturing processes

• Making changes in the flow of materials

• Taking into account time, effort and expense of qualification and requalification (functionality, shelf-life, etc.)

• Looking at transportation, storage and packaging

Biopharmaceutical Market in India

Business Success in India Depends on the Partner’s Ability to Deliver Quality - Quickly and Efficiently

Facility Layout – Ready for the Change?

The demand for high quality pharmaceutical drugs is reflected in the design of manufacturing systems. This is primarily driven by regulatory requirements, besides those related to production plant operations, and the process focuses on eliminating or containing the potential risk of contaminating active pharmaceutical ingredients. As a result, this effort includes engineering operations that are designed to run as completely closed manufacturing processes.

If this is not possible, engineers must design production facilities that either minimize or entirely rule out the risk of contamination. Due to the multi-product nature of many production systems, their design is engineered for protection under worst case scenarios. In other words, process suites for upstream and downstream processing areas are often designed to meet the requirements of ISO 7 or 8 clean room classification. This places high demands on the design quality of a clean room facility and on the associated ventilation and climate control equipment. In addition to the investment capital required to install such equipment, the cost of operating consumes a major share of a manufacturing facility’s budget.

(ID:42604013)