Pharmaceutical Preparation Machine Sterile Chamber Segmentation

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Solution Overview

Problem

Existing machines for preparing cytostatic drugs expose operators to risks and compromise sterility during loading and unloading, as the chamber housing the magazine is not maintained in sterile conditions when opened for these operations.

Innovation Solution

A machine design with a box-type holding frame subdivided into upper and lower chambers, where the upper chamber houses a magazine, dosage station, and gripping device, and is maintained in sterile conditions using a pneumatic device with sterilizing filters, preventing external contamination during loading and unloading through a sterile air flow system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the first chamber is opened to allow loading and unloading operations of the magazine, then the operator can access the magazine for loading and unloading containers, but the first chamber is exposed to the external environment which compromises sterility and exposes the operator to cytostatic drug risks

Engineering Contradiction:

Improveaccess to magazine for loading and unloadingVSAvoidsterility compromise and operator exposure to cytostatic drugs

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

A second chamber is introduced as an intermediary between the external environment and the first chamber. The second chamber houses the magazine and can be opened for loading/unloading operations without exposing the first chamber to the external environment. This intermediary chamber acts as a buffer that maintains sterility while allowing operator access to the magazine.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The holding frame is divided into two separate chambers: a first chamber that maintains sterile conditions and houses the dosage station, and a second chamber that houses the magazine and can be opened for operations. This segmentation allows independent access to the magazine without compromising the sterile environment of the first chamber.

Inventive Principle:

Principle #1Segmentation

2Reliability

If the first chamber is maintained in sterile conditions, then operator safety and product sterility are protected, but access to the magazine for loading and unloading becomes more difficult

Engineering Contradiction:

Improvesterility maintenance and operator safetyVSAvoidaccess to magazine

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The second chamber serves as an intermediary that allows magazine access operations to occur without breaching the sterile barrier of the first chamber. Operators interact with containers in the second chamber, which can be opened, while the first chamber remains sealed and sterile.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

By segmenting the holding frame into two chambers with different access requirements, the system maintains sterility in the first chamber while providing operational access to the magazine in the second chamber. Each chamber can be independently accessed based on operational needs.

Inventive Principle:

Principle #1Segmentation

3Object-affected harmful factors

If a sealed first chamber is used to maintain sterility, then contamination is prevented, but the complexity of the machine structure increases

Engineering Contradiction:

Improvecontamination preventionVSAvoidchamber structure and communication system

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The holding frame is segmented into two chambers that are substantially hermetically sealed relative to each other and to the external environment. This segmentation provides a straightforward structural solution for maintaining sterility without requiring complex active filtration or continuous monitoring systems.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The second chamber acts as an intermediary that simplifies the overall system by providing a dedicated access point for magazine operations. This intermediary structure allows the first chamber to remain simply sealed without requiring complex active sterility maintenance systems.

Inventive Principle:

Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The machine ensures operator safety and maintains sterility during the preparation of pharmaceutical products by preventing the entry of external air and maintaining a sterile environment, even when the upper chamber is accessed for loading and unloading.

Implementation Method 1

a pneumatic device with sterilizing filters, preventing external contamination during loading and unloading through a sterile air flow system

Methodology Applied

Scientific EffectPneumatic device with sterilizing filters: Filter (physical)

Data Source

PatentUS8905086B2Machine for the preparation of pharmaceutical products

Publication Date: 2014.12.09 OMNICELL SRL

AI summary

A machine for the preparation of pharmaceutical products is provided with a gripping and carrier device to transfer at least one container between a magazine and a dosage station for the preparation of a pharmaceutical product, and a box-type holding frame defining a chamber for the housing of magazine, gripping and carrier device, and dosage station; the chamber displaying an access aperture to magazine and being crossed by a sterile air flow adapted to avoid the entry of air from the external environment through aperture itself.