Aseptic Cover Removal Monitoring via Diffuse Light Reflection
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Solution Overview
Problem
Current pharmaceutical filling systems are bulky and expensive, making them unsuitable for small-scale production and development environments, and often require complex aseptic handling procedures that are not efficiently addressed by existing technologies.
Innovation Solution
A compact filling system with a sterilizable chamber and a planar rotary stage that maintains aseptic conditions, using a filling station and cover removal station to iteratively and serially fill pharmaceutical containers with a pharmaceutical fluid substance, eliminating the need for vibratory bowls and gloves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pharmaceutical filling systems are used, then aseptic handling is maintained, but the equipment becomes bulky and expensive
Solution Approach 1:
The patent implements nesting by placing multiple container nests within a single chamber. Each nest holds multiple containers, allowing the system to process many containers in one chamber without requiring proportionally more chamber volume. This nested arrangement enables compact equipment design while maintaining aseptic handling of numerous containers simultaneously.
Solution Approach 2:
The chamber serves multiple functions: it maintains aseptic conditions, holds multiple nested container nests, accommodates various container sizes and configurations, and integrates with filling mechanisms. This multi-functionality allows a single compact chamber to replace what would traditionally require multiple separate pieces of equipment, reducing overall equipment volume while preserving aseptic reliability.
2Reliability
If traditional filling systems are used, then aseptic conditions are maintained, but the cost increases
Solution Approach 1:
By nesting multiple container nests within a single chamber, the system reduces the total number of chambers and associated sealing mechanisms required. This nesting strategy lowers manufacturing costs by minimizing redundant components while maintaining aseptic conditions across all containers processed in parallel within the same controlled environment.
Solution Approach 2:
The patent merges multiple container handling operations into a single chamber environment. Instead of requiring separate aseptic chambers for each container or small group of containers, the system combines multiple nests and containers in one chamber, reducing the total equipment count and associated manufacturing costs while preserving aseptic reliability through a single controlled environment.
3Productivity
If vibratory bowls and escapements are used for container handling, then containers are transferred, but the equipment becomes more complex
Solution Approach 1:
The patent extracts and eliminates complex mechanical transfer mechanisms like vibratory bowls and escapements from the system. Instead, containers are transferred using simpler, more direct methods such as robotic manipulators or automated picking/placing mechanisms that operate within the chamber, maintaining productivity while significantly reducing device complexity.
Solution Approach 2:
The invention replaces traditional mechanical vibratory bowl and escapement systems with alternative mechanisms such as robotic arms, automated grippers, or computer-controlled positioning systems. These substitutions maintain the ability to transfer containers efficiently but eliminate the complex mechanical linkages, cams, and vibratory components inherent in traditional systems, thereby reducing overall device complexity.
4Reliability
If gloves are used for operator access to the chamber, then aseptic handling is maintained, but the operation becomes less efficient
Solution Approach 1:
The system is designed to be self-sufficient regarding aseptic maintenance. Automated cleaning mechanisms, UV irradiation systems, or chemical sterilization processes are integrated into the chamber to maintain aseptic conditions without requiring operator intervention through gloves. This self-service approach preserves aseptic reliability while eliminating the operational inefficiencies associated with glove use.
Solution Approach 2:
The patent replaces manual operator manipulation through gloves with automated robotic systems or computer-controlled mechanisms for any necessary chamber access or container handling. This substitution maintains aseptic conditions through automated sterile barriers while dramatically improving operational efficiency by eliminating the dexterity limitations and time constraints imposed by glove use.
Data Source
AI summary
A system is presented for monitoring and controlling in a sterilizable environment the peeling of a cover from a tub sealed by the cover. The system employs a platform having a fiducial source locating structure for holding the tub, a cover removal station disposed to engage with the cover and to peel the cover from the tub, a light source disposed to illuminate a portion of the platform proximate the cover removal station, a light sensor sensitive to light from the light source and disposed to preferentially collect and measure light diffusely reflected from the illuminated portion of the platform, and a controller with software to operate the system. An associated method for monitoring and controlling the peeling of the cover involves moving a peeled portion of the cover into a predetermined peeling monitor zone within the illuminated portion of the platform, and measuring an intensity of light from the light source diffusely reflected specifically from the peeling monitor zone. The positioning of the elements of the system and the peeling monitor zone allow measured light intensity to be employed as a control measure for the peeling process.