Design Qualification Protocol for Terminal Sterilization Load Carts in IV Infusions

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Terminal Sterilization Load Carts/Racks used for holding IV infusion bags/bottles in the autoclave meet the specified requirements and are suitable for their intended use.

Scope

This protocol applies to the validation of Terminal Sterilization Load Carts/Racks in the Production area for IV Infusions (LVP/SVP – Bags/Bottles).

Responsibilities

• Validation Team: Responsible for executing the DQ protocol.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol.
• Production: Responsible for providing operational input and ensuring compliance with the DQ protocol.

Prerequisites

• Completion of User Requirement Specification (URS).
• Availability of Terminal Sterilization Load Carts/Racks.
• Access to relevant standard operating procedures (SOPs).

Equipment Description

The Terminal Sterilization Load Carts/Racks are designed to hold IV infusion bags and bottles securely during the autoclave process. The equipment is constructed from stainless steel, ensuring durability and resistance to sterilization processes.

Test Plan

Detailed Test Cases

Test Case T1: Evaluate Load Configuration Stability

Objective: To confirm that the load configuration remains stable during the autoclave cycle.

Procedure:
1. Load the Terminal Sterilization Load Carts/Racks with IV infusion bags/bottles as per the defined configuration.
2. Initiate the autoclave cycle and monitor for any movement or shifting of the load.

Acceptance Criteria: The load configuration must not shift or fall during the autoclave cycle.

Evidence: Photographic documentation and stability logs must be collected and reviewed.

Deviations

Any deviations from the acceptance criteria must be documented, including the reason for the deviation and proposed corrective actions.

Approvals

Prepared by: [Your Name]       Approved by: [Approver’s Name]

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