Freeze Dryer Dual Sealing System for Isolator Sterilization

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Solution Overview

Problem

Freeze dryers in the pharmaceutical industry face contamination risks due to the leakage of harsh chemical sanitizing agents, such as vaporized hydrogen peroxide, from isolators or clean rooms into the freeze dryer chamber, especially during sanitization processes, which can compromise the sterility and effectiveness of pharmaceutical products.

Innovation Solution

A dual sealing system is implemented, comprising a static seal (e.g., O-ring) for vacuum maintenance and an interactive seal (e.g., inflatable gasket), with an optional nitrogen barrier between them, to prevent external atmosphere and sanitizing agents from entering the freeze dryer chamber, allowing for simultaneous freeze drying and isolator sanitization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single inflatable gasket seal is used between the chamber and door, then the vacuum seal is maintained, but the protection against contamination from harsh chemical agents is insufficient

Engineering Contradiction:

Improveprotection against contaminationVSAvoidsealing system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sealing system is divided into multiple independent sealing means positioned at different locations between the chamber and door. The first sealing means provides a primary vacuum seal, while the second sealing means provides an additional barrier against chemical agents. This segmentation allows each seal to perform its specific function independently, enhancing overall protection without requiring a completely complex new system design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dual sealing system acts as a pre-established protective barrier before harsh chemical agents can penetrate into the chamber. By having multiple seals in place beforehand, the system cushions against potential contamination during isolator sanitization, preventing chemical agents from reaching the chamber and its contents.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Ease of operation

If the isolator is sanitized with harsh chemical agents, then the isolator is cleaned and sterilized, but the chemical agents may leak into the freeze dryer chamber causing contamination

Engineering Contradiction:

Improveisolator sanitization capabilityVSAvoidchemical agent leakage

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dual sealing system applies a preliminary protective action by establishing multiple barriers before the sanitization process begins. These seals preemptively block the path of harsh chemical agents, preventing them from entering the chamber during isolator cleaning operations.

Inventive Principle:

Principle #9Preliminary anti-action

3Reliability

If the freeze dryer chamber is sealed tightly to prevent contamination, then sterility is maintained, but access for loading and removal of vials becomes more difficult

Engineering Contradiction:

Improvesterility maintenanceVSAvoidvial access difficulty

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The slot door is designed to move vertically along guide tracks, transitioning between a closed position that maintains the vacuum seal and an open position that allows access for loading and removal of vials. This dynamic movement allows the system to switch between maintaining sterility and enabling operation as needed, with the door's position changing based on the operational requirement.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The slot door acts as an intermediary element between the sealed chamber environment and the external loading area. It provides a controlled interface that allows vials to be transferred while maintaining the integrity of the vacuum seal, mediating between the need for access and the need for sterility.

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 dual sealing system effectively prevents contamination of the freeze dryer chamber during isolator sanitization, ensuring the sterility of pharmaceutical products and enabling continuous freeze drying operations even during sanitization cycles, while also allowing for the sanitization of multiple freeze dryers within a single isolator.

Implementation Method 1

The static seal provides a vacuum seal to maintain pressure in the freeze dryer

Methodology Applied

Scientific EffectVacuum seal: Vacuum

Implementation Method 2

the other being an interactive seal, e.g. an inflatable gasket. The static seal provides a vacuum seal to maintain pressure in the freeze dryer while the interactive seal prevents the atmosphere outside the freeze dryer from entering into the freeze dryer

Methodology Applied

Scientific EffectPhysical barrier: Physical Containment

Implementation Method 3

Another embodiment of the invention comprises providing a nitrogen barrier between the two sealing means, wherein the nitrogen barrier further prevents the outside atmosphere, such as that in the isolator, from entering the freeze dryer

Methodology Applied

Scientific EffectGas barrier: Diffusion Barrier

Data Source

PatentEP2089645B1Freeze dryer barrier system

Publication Date: 2013.02.13 IMA LIFE NORTH AMERICA INC

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AI summary

This invention is directed to freeze dryers used in the pharmaceutical industry, and in particular, to a barrier system for freeze dryers located in an isolator or clean room facilitate sterilization of the isolator.