Brief Description

This Performance Qualification (PQ) Protocol is prepared for the 30-inch Vibro Sifter used in pharmaceutical manufacturing. Its purpose is to confirm that the equipment performs consistently, repeatedly, and within the approved operating range. The Vibro Sifter uses a vibrating screen to separate fine material from coarse material and helps achieve uniform grading during the sifting process. The protocol covers equipment details, responsibilities, pre-qualification requirements, tests, acceptance criteria, documents, deviations, and change control. Before PQ, Design Qualification, Installation Qualification, Operational Qualification, and relevant operation, cleaning, and maintenance SOPs should be available. Performance is checked using placebo material and drug products. During testing, the correct sieve is installed, material is loaded, sifting is performed, operation time is recorded, and sieve integrity is checked before and after use. Successful completion provides documented evidence that the Vibro Sifter is suitable for routine production use. It also supports reliable, controlled, and efficient material processing activities.

Impact Assessment

The Performance Qualification of the 30-inch Vibro Sifter will have a positive impact on the manufacturing process. It will confirm that the equipment is working properly and can perform sifting consistently during routine production. The study checks important points such as equipment condition, correct sieve installation, sifting time, sieve integrity, and overall machine performance. Before starting PQ, required qualifications such as DQ, IQ, OQ, and related SOPs should be completed and approved. Proper qualification will reduce the risk of improper sifting, damaged sieves, uneven material size, and process variation. It also helps ensure that fine material passes through the selected sieve while coarse material is retained as required. Any deviation or non-compliance found during PQ will be recorded, reviewed, and evaluated by Quality Assurance. Overall, successful PQ provides confidence that the Vibro Sifter is suitable for routine pharmaceutical production and supports consistent product quality.

Critical Process Parameters (CPP) & Critical Quality Attributes (CQA)

The protocol does not explicitly label any item as CPP or CQA. However, it identifies the operating checks and acceptance criteria used to demonstrate satisfactory Vibro Sifter performance. Based on those protocol requirements, the following can be considered qualification-critical:

Type	Parameter / Attribute	Requirement / Importance
CPP	Sieve mesh size	Use the specified sieve as per BMR.
CPP	Material loading quantity	Load approximately 80% of the top-lid volume.
CPP	Sifting time	Record and compare with the required standard time.
CPP	Equipment operating condition	Operate within the established OQ operating range.
CPP	Vibration setting	Should provide effective and uniform sifting; vibration can be adjusted using eccentric weights.
CQA	Sifting efficiency	Material should be sifted effectively through the selected sieve.
CQA	Sieve integrity	Sieve must remain intact before and after sifting.
CQA	Uniform material grading	Material should be separated uniformly according to sieve size.
CQA	Absence of coarse material in sifted portion	Oversized particles should remain above the sieve.
CQA	Consistent equipment performance	Results should meet predefined acceptance criteria during PQ.

The protocol specifically identifies sifting efficiency, sieve integrity, and required process time as key performance checks/acceptance criteria.

FMEA – Performance Qualification of Vibro Sifter 30″

The protocol does not contain a ready-made FMEA. The following FMEA is developed from the PQ activities, checks, acceptance criteria, deviation requirements, and equipment description in the protocol. The S/O/D scores are proposed risk-assessment values, not values stated in the source.

Scoring: Severity (S), Occurrence (O), Detection (D): 1–5
RPN = S × O × D

S.No.	Process / Parameter	Potential Failure Mode	Possible Impact	Possible Cause	Existing / Proposed Control	S	O	D	RPN	Risk
1	Document verification	DQ/IQ/OQ or SOP not available/approved	PQ may be performed without proper qualification status	Incomplete documentation	Verify availability, completeness and approval before PQ	4	2	2	16	Low
2	Sieve selection	Wrong mesh sieve installed	Incorrect particle-size separation	Wrong sieve selection / BMR not followed	Verify specified mesh size as per BMR	5	2	2	20	Medium
3	Material loading	Excessive or incorrect loading	Poor sifting efficiency or increased sifting time	Overloading of hopper	Load approximately 80% of top-lid volume	3	2	2	12	Low
4	Sifting operation	Improper vibration / poor machine performance	Non-uniform sifting	Incorrect eccentric-weight setting or equipment problem	Operate within established OQ range and observe performance	4	2	3	24	Medium
5	Sieve integrity	Sieve damaged during operation	Coarse particles may pass into sifted material	Worn or damaged sieve	Check sieve integrity before and after operation	5	2	2	20	Medium
6	Sifting time	Sifting takes longer than standard	Process variation and reduced efficiency	Improper loading, sieve condition or equipment performance	Record sifting time and compare with standard	3	2	2	12	Low
7	Sifting efficiency	Material is not sifted properly	Inconsistent material grading	Wrong sieve, poor vibration or excessive load	Verify performance using placebo and drug product	5	2	3	30	Medium
8	Deviation handling	Deviation not recorded or assessed	Unacceptable equipment performance may be overlooked	Inadequate documentation / review	Record deviation and obtain QA assessment	4	2	2	16	Low

Conclusion

The main risks during Vibro Sifter PQ are wrong sieve selection, damaged sieve, poor sifting efficiency, improper loading, and abnormal equipment performance. Controls such as checking the correct sieve, maintaining approximately 80% loading, recording sifting time, checking sieve integrity before and after use, and reviewing deviations through QA help reduce these risks. No high-risk item is identified in this proposed FMEA when the defined controls are properly followed.

Questions & Answers

1. What is the purpose of the Performance Qualification of Vibro Sifter 30″?
   The purpose is to confirm that the Vibro Sifter performs consistently, repeatedly, and within its established operating range.
2. What equipment is covered in this PQ protocol?
   The protocol covers the Performance Qualification of a 30-inch Vibro Sifter manufactured by Elicon Pharma.
3. What is the main function of a Vibro Sifter?
   It is used to separate and grade material using a vibrating screen. Fine material passes through the sieve, while coarse material remains above it.
4. Which departments are involved in the PQ activity?
   Quality Assurance, Production, and Engineering are involved in the Performance Qualification activity.
5. What qualifications should be completed before starting PQ?
   Design Qualification, Installation Qualification, and Operational Qualification should be completed before PQ.
6. Which SOPs should be available before PQ?
   SOP for Operation & Cleaning and SOP for Preventive Maintenance of the Vibro Sifter should be available.
7. Why is Performance Qualification performed after OQ?
   PQ is performed to establish that operating parameters are followed, critical variables are controlled, and the equipment gives the desired output.
8. How often should the Vibro Sifter be qualified?
   Qualification is required once every two years and also after a major breakdown or major modification.
9. What documents are verified during PQ?
   DQ, IQ, OQ documents and the relevant operation, cleaning, and preventive maintenance SOPs are verified.
10. What is checked during performance testing?
    Sifting efficiency is checked during performance testing.
11. What type of material is used for PQ testing?
    The protocol includes performance evaluation using both placebo formulation and drug products.
12. How much material should be loaded into the Vibro Sifter?
    The protocol states that material should be loaded to approximately 80% of the total volume of the top lid.
13. What should be checked before and after sifting?
    The integrity of the sieve should be visually checked before and after the sifting operation.
14. What is the acceptance criterion for sieve integrity?
    The sieve should remain intact before and after the operation.
15. What is checked regarding sifting time?
    The sifting operation time is recorded and should be relevant to the established standard.
16. What happens if a deviation is observed during PQ?
    The deviation should be reported to the Head of Quality Assurance, documented, and its impact on equipment operation and performance should be evaluated.
17. What happens if change control is required during PQ?
    The Head QA should be informed, details should be documented, and the impact of the change on equipment operation and performance should be assessed.
18. When is the Vibro Sifter considered successfully qualified?
    It is considered successfully qualified when all required checks are completed and the test results meet the predefined acceptance criteria.