High Level Aseptic Filling

How to Maintain Aseptic Conditions When Filling Vials

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Current practices require the use of Riboflavin (vitamin B2) diluted in water. This substance must be introduced inside the circuit before being submitted to the CIP procedure (Cleaning in place). If there is any residual trace after the washing cycle, the substance acts as a marker indicating whether the washing cycle has been successful or if, on the contrary, the area has not been effectively washed.

Faster, Safer and More Precise

Further advantages are related to the Micro Motion flow meters’ capability to handle versatile multi variable measures. For example, the detection of the temperature is an essential feature for certifying that inside the circuit, during sterilization, you have actually been achieved and maintained the data set by the Customer in PQ phase.

The same flow mass measurement can be used to measure the amount of detergent used. Temperature, density and/or possible presence of foam in the flow measurement have no influence, the mass flow returns the exact amount of detergent that is passed along the circuit.

We can well understand how the batch change is faster than it typically is. In addition to not having to replace the pumps or any other mechanical parts, washing and sterilization phases are done without dismantling measuring instruments. All of that in accordance with GAMP 4 Guidelines and CFR 21-11 Specifications.

A Technology Intended to go a Long Way

The positive experience in the field has led Ima Life management to evaluate further developments linked with mass technology applications on aseptic processing filling machines.

The collaboration with Emerson Process Management has started five years ago, becoming a true partnership. This allowed Ima technicians to be confident on the technical validity of the solution.

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