Hot and Cold Bath Cleaning Validation Guide

The cleaning validation plan for hot and cold cylinders in the second-floor workshop includes the following key points:

1. **Scope and Responsibilities**:

- The plan applies to the cleaning validation of hot and cold cylinders.

- Responsibilities are divided among the Production Technology Department, Quality Control Department, QA Validation Manager, Quality Manager, and Quality Director, covering drafting, implementation, inspection, coordination, and approval of the validation process.

2. **Objectives**:

- **Physical Inspection**: Ensure minimal residual stains and odor after cleaning, confirming the effectiveness of the cleaning method.

- **Disinfection Effectiveness**: Verify that cleaning and disinfection prevent contamination, measured by colony counts in sampled areas after disinfection.

3. **Cleaning Methods**:

- Equipment is cleaned after each batch of Yinqiao Mixture according to the "Hot and Cold Tank Cleaning SOP."

4. **Sampling Locations**:

- Focus on the inner walls and agitator blades, identified as the most challenging areas to clean.

5. **Verification Methods**:

- **Physical Inspection**: Wipe cleaned areas with a white cloth and inspect visually for stains.

- **Residue Limit Test**: Analyze final rinse water using UV analysis, ensuring residue limits are within acceptable levels.

- **Microbiological Verification**: Use sterile swabs to test for colony counts, with acceptance criteria set at ≤20 CFU/10 cm².

6. **Validation Process**:

- Data is collected and evaluated over three consecutive batches, following the cleaning and sampling methods outlined.

- Results are recorded, analyzed, and conclusions are drawn based on the validation process.