#PowellRemarks Infrared Sterilization Procedure for

Marine Collagen (MCP-TC01)

1. Purpose

To outline the validated procedure for sterilizing marine collagen using Infrared (IR)

radiation to achieve microbial load reduction in accordance with microbiological safety

standards.

2. Scope

This procedure applies to all batches of marine collagen intended for use in food,

cosmetic, or pharmaceutical applications requiring IR sterilization.

3. Responsibilities

- Production Supervisor: Ensures correct equipment setup and execution.

- Quality Assurance (QA): Reviews and verifies sterilization records and microbiological

test results.

- Operators: Carry out sterilization steps and record process parameters.

4. Materials and Equipment

- Infrared sterilization chamber (calibrated and validated)

- Temperature and time monitoring devices

- Collagen raw material (pre-dried and sieved if applicable)

- Clean containers and tools (sterile or sanitized)

5. Procedure

5.1 Pre-Treatment

- Ensure marine collagen is dry and within specified moisture content (≤10%).

- Sieve the material to ensure uniform particle size distribution if required.

- Load collagen into IR-permeable, heat-resistant trays in a thin, even layer.

5.2 Sterilization Parameters

- IR Wavelength Range: 0.78 – 3.0 µm (Near-IR to Mid-IR spectrum)

- Surface Temperature: 100°C to 130°C (depending on batch sensitivity)

- Exposure Time: 5–15 minutes, optimized to reach target log reduction without