**Failure Modes and Effects Analysis (FMEA) for Capsule Filling Machine Performance Qualification:**

**1. Identify the Section:**

- Section: Capsule Filling Mechanism

**2. List Critical Quality Attributes (CQAs):**

- a. Capsule Fill Weight

- b. Capsule Integrity

- c. Fill Accuracy

- d. Machine Speed

**3. Identify Potential Failure Modes:**

- a. Fill weight deviation

- b. Capsule breakage

- c. Inaccurate fill volume

- d. Machine jamming

**4. Assess Severity (S), Occurrence (O), and Detection (D):**

- a. Fill weight deviation (S: 4, O: 3, D: 2)

- b. Capsule breakage (S: 3, O: 2, D: 4)

- c. Inaccurate fill volume (S: 4, O: 3, D: 3)

- d. Machine jamming (S: 3, O: 2, D: 3)

**5. Calculate Risk Priority Number (RPN):**

- a. RPN = S * O * D

- i. Fill weight deviation RPN = 4 * 3 * 2 = 24

- ii. Capsule breakage RPN = 3 * 2 * 4 = 24

- iii. Inaccurate fill volume RPN = 4 * 3 * 3 = 36

- iv. Machine jamming RPN = 3 * 2 * 3 = 18

- a. Fill weight deviation

- i. Implement weight control sensors

- ii. Regular calibration of weighing systems

- b. Capsule breakage

- i. Improve capsule handling mechanisms

- ii. Implement real-time monitoring for breakage

- c. Inaccurate fill volume

- i. Optimize dosing mechanisms

- ii. Implement feedback control for fill accuracy

- d. Machine jamming

- i. Regular maintenance schedules

- ii. Implement sensors for detecting potential jams

**7. Reassess RPN after Mitigation:**

- a. Fill weight deviation RPN = 2 * 2 * 2 = 8

- b. Capsule breakage RPN = 2 * 2 * 2 = 8

- c. Inaccurate fill volume RPN = 2 * 2 * 3 = 12

- d. Machine jamming RPN = 2 * 2 * 3 = 12

**8. Final Steps:**

- a. Monitor and continuously improve mitigation measures

- b. Document and communicate FMEA findings and actions

- c. Incorporate FMEA into routine machine performance assessments

This FMEA helps identify, prioritize, and address potential risks in the capsule filling machine's critical
areas during performance qualification. Regular reviews and updates ensure ongoing product quality
and process improvement.
۲

Absolutely, I'll outline the Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs),
perform a Failure Mode and Effects Analysis (FMEA) to identify potential failure modes, effects, and
their severities, and then calculate the Risk Priority Numbers (RPNs) for each.

### Critical Process Parameters (CPPs):

1. **Fill Weight Control:** Ensure precise control over the amount of powder in each capsule.

2. **Powder Flowability:** Monitor and optimize the flow characteristics of the powder for consistent
filling.

3. **Capsule Alignment:** Maintain accuracy in aligning capsules for proper filling.

4. **Compression Force:** Regulate the force applied during the compression stage to avoid
over/under-compression.

5. **Machine Speed:** Control the machine speed for consistent and accurate filling without
compromising quality.

### Critical Quality Attributes (CQAs):

1. **Weight Variation:** Minimal variation in the weight of filled capsules.

2. **Content Uniformity:** Uniform distribution of the active ingredient in the filled capsules.

3. **Capsule Integrity:** Ensure capsules are free from damage or deformation.

4. **Disintegration Time:** Capsules disintegrate within specified time limits for proper dissolution.

5. **Moisture Content:** Maintain optimal moisture levels in powder and capsules.

### Failure Mode and Effects Analysis (FMEA) with RPN Calculation:

1. **Fill Weight Control:**

- **Failure Mode:** Inaccurate weight measurement.

- **Effect:** Incorrect dosing.

- **Severity (S):** 8

- **Occurrence (O):** 6
 - **Detection (D):** 5

- **RPN (S x O x D):** 8 x 6 x 5 = 240

2. **Powder Flowability:**

- **Failure Mode:** Powder clogging in the filling mechanism.

- **Effect:** Incomplete fills or irregular dosing.

- **Severity (S):** 7

- **Occurrence (O):** 5

- **Detection (D):** 7

- **RPN (S x O x D):** 7 x 5 x 7 = 245

3. **Capsule Alignment:**

- **Failure Mode:** Misalignment of capsules.

- **Effect:** Incorrect filling or spillage.

- **Severity (S):** 6

- **Occurrence (O):** 4

- **Detection (D):** 8

- **RPN (S x O x D):** 6 x 4 x 8 = 192

4. **Compression Force:**

- **Failure Mode:** Excessive force applied.

- **Effect:** Capsules damaged.

- **Severity (S):** 9

- **Occurrence (O):** 3

- **Detection (D):** 6

- **RPN (S x O x D):** 9 x 3 x 6 = 162

5. **Machine Speed:**

- **Failure Mode:** Inconsistent speed control.

- **Severity (S):** 7

- **Occurrence (O):** 5

- **Detection (D):** 7

- **RPN (S x O x D):** 7 x 5 x 7 = 245

These RPN values help prioritize the identified risks. The higher the RPN, the higher the priority for
implementing measures to reduce or eliminate the associated risks.

Absolutely! Here's a comprehensive Sampling Plan and Standard Operating Procedure (SOP) for an
Automatic Capsule Filling Machine:

### Sampling Plan:

#### Purpose:

The purpose of this sampling plan is to outline the procedures for sampling capsules filled by the
automatic capsule filling machine to ensure compliance with quality standards and specifications.

#### Sampling Requirements:

1. **Performance Qualification (PQ):**

- Random selection of capsules filled by the machine for testing.

- Sampling across different machine settings (speed, compression force, fill weight).

2. **Functional Qualification (FQ):**

- Sampling of machine components (feeders, alignment systems, compression units) for functionality
testing.

#### Sampling Procedure:

- Set up the machine according to predefined operational parameters and specifications.

- Randomly sample capsules filled by the machine at various settings (speed, compression force, fill
weight).

- Collect samples for weight variation, content uniformity, disintegration time, and moisture content
testing.

- Record and analyze the test results against predetermined acceptance criteria.

2. **Functional Qualification (FQ):**

- Inspect and select machine components (feeders, alignment systems, compression units) for
functionality testing.

- Run mock production cycles under varying conditions to assess functionality and performance.

- Record observations and ensure components operate within specified tolerances.

### Standard Operating Procedure (SOP):

#### Purpose:

The purpose of this SOP is to define the step-by-step process for the operation and sampling of the
Automatic Capsule Filling Machine.

#### Procedure:

1. **Preparation:**

- Gather necessary documentation, including manuals, SOPs, and validation protocols.

- Ensure the machine is clean, sanitized, and calibrated as per standard operating procedures.

- Verify availability and functionality of required tools and components.

2. **Performance Qualification (PQ):**

- Set up the automatic capsule filling machine according to predefined operational parameters.
 - Randomly select capsules filled by the machine across different settings (speed, compression force,
fill weight).

- Collect samples for weight variation, content uniformity, disintegration time, and moisture content
testing.

- Perform tests according to established protocols and record results.

3. **Functional Qualification (FQ):**

- Inspect and select machine components for functionality testing.

- Conduct simulated production cycles under varying conditions to assess component performance.

- Record observations, noting any deviations or malfunctions encountered during testing.

4. **Documentation and Reporting:**

- Document all procedures, observations, and test results in the qualification report.

- Generate a summary report indicating compliance with acceptance criteria.

- Obtain necessary approvals and signatures from authorized personnel.

5. **Conclusion:**

- Based on the findings, make recommendations for adjustments, maintenance, or further testing if
required.

- Complete the qualification process and ensure proper storage of all documentation for future
reference.

This Sampling Plan and SOP provide a structured approach to operating the automatic capsule filling
machine and ensuring compliance with quality standards through thorough sampling and testing
procedures. Adjustments can be made to suit specific regulatory requirements and the machine's
unique features.