Containment in Mixing Processes: Safe Solutions for Operator and Product Protection
Containment in mixing processes plays an increasingly important role, as it ensures both operator safety and product protection.
Operator safety: Many powdered or chemical substances can be harmful to health during filling, mixing or emptying. Containment prevents these substances from entering the ambient air. This eliminates the risk of exposure, allergies, toxic reactions or long-term health damage. This is particularly essential for highly active substances such as APIs or toxic chemicals.
Product protection: When mixing sensitive or high-purity substances, any cross-contamination is critical. Foreign particles, moisture or bacteria can severely compromise quality. Containment ensures that the product remains in a completely closed environment throughout the entire process. This guarantees purity and helps ensure compliance with regulatory requirements.
In modern production environments – particularly in the pharmaceutical, chemical and food industries – mixing processes often generate dust, aerosols or other potentially hazardous substances. Without effective containment measures, these substances can endanger the health of staff or compromise product quality. A controlled, enclosed containment system prevents precisely that: it keeps the product where it belongs, whilst protecting the people working with the plant. Regulatory requirements, such as the REACH Regulation, also stipulate containment as an important measure, meaning that it is increasingly being promoted by the authorities too.
LÖDIGE is responding to this development and has introduced the FKM Containment, the first mixer in its range specifically designed for use up to OEB Level 5. This new machine design is based on the Ploughshare Mixer developed and established by Lödige, which enables highest mixing accuracy in shortest possible mixing time.
The machine has been specially adapted for containment applications by optimally complementing the mixing system with suitable feeding and discharge systems, a two-stage filter system, a flexible isolator for machine access and modifications of the seals. An automatic cleaning system (WIP or CIP) ensures reliable and reproducible machine cleaning.
The features of the FKM Containment in detail:
- The use of split butterfly valves from renowned manufacturers enables dust-free product feeding and discharge up to OEB Level 5. Selecting specific flap models takes place according to our customer’s existing plant standards.
- Single-use systems offer maximum flexibility and minimize cleaning efforts, as product contact parts can be disposed of after the process. Systems using bags (e.g. for pre-weighed products) or endless foil liners (e.g. for machine emptying or sampling) are just two of many possible solutions.
- Enclosing the inspection flaps within flexible isolators fitted with glove ports allows for interventions, visual inspection or minor manual adjustments inside the machine without breaching containment. The isolators are designed in a way which ensures that the inspection flaps can be fully opened.
- The modification of dynamically loaded seals (e.g. for mixing elements, choppers or discharge door) provides the system with permanent protection against potential leaks, even in highly stressed areas.
- Machine exhaust air is treated via a two-stage filter system, comprising a pneumatic cleaning mechanism for the first filter stage and a HEPA filter as the second filter stage. Filter replacement for both stages is carried out using a BiBo (Bag in/Bag out) exchange system, which prevents the operator from contact with contaminated filter surfaces.
- A containment-compatible sampler enables taking representative samples during the mixing process without opening the system. The samples are discharged using single-use systems. Product quality can thus be monitored without exposing operating personnel to any risk.
- The use of a partially or fully automated WIP or CIP system for machine cleaning ensures automated and reproducible machine cleaning, eliminating the need to open the machine.
The specific containment measures required and implemented are agreed and determined customized, with a focus on maximum flexibility. As with all our other machines and systems, our customers’ products and processes are our focus, and these determine the final machine design.