OBJECTIVE:
To lay down a Procedure for Vibro energy sifter.
SCOPE:
The scope of this SOP is for operating procedure for Vibro energy sifter.
RESPONSIBILITY:
- Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
- Initiator Executive/Designee: Production shall ensure the compliance of the SOP
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT VIBRO ENERGY SIFTER:
A Vibro Energy Sifter is a crucial piece of equipment in the pharmaceutical industry, used for separating and classifying powders and granules. It operates through vibratory motion generated by an electric motor, which transmits energy to the screen mesh, allowing materials to pass through based on particle size. This process ensures uniform particle distribution and removes contaminants or oversized materials. The sifter is made of stainless steel to maintain hygiene and is easy to clean, making it ideal for pharmaceutical applications. Its efficient operation enhances product quality, consistency, and compliance with industry regulations, playing a vital role in drug manufacturing.
PROCEDURE:
- Check the area and machine for cleanliness.
- Take line clearance from QA, before starting the operation.
- Check the room temperature and humidity as per the specifications mentioned in the BMR to be processed. If conditions do not meet the specifications inform the Executive and proceed only when the required conditions are obtained.
- Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the sifter.
- Bring all the materials of required quantity as per the BMR to be sifted in the sifting area.
- Sift the materials using specified sieves as mentioned in the BMR of that product.
Caution: During sifting of high potent drugs sifting shall be carried out in a specific area on sieve to avoid adherence of material to side wall with proper geometrical mixing.
Set- Up
Fixing of the Sieve
Check the sieve size for correctness as mentioned in the BMR.
Check the gasket for its integrity.Place a self-cleaning kit on the table frame.
Place the spacer assembly and gasket.Place the screen on top of the self-cleaning kit.
Place another gasket and clamp it with table frame.
Place the spacer frame on top and clamp it with clamp which is provided
Fixing of Cover
Place the blank tension ring with the gasket on the top of spacing frame.
Place the cover above the spacing frame.
Align the cover from all sides with respect to hopper.
Clamp it properly
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OPERATION:
Put the power plug into the power supply socket.
Switch on the mains and ensure that it is working properly. Switch off the sifter mains.
Caution: In case of abnormal noise inform maintenance to rectify the problem; do not adjust the sifter parts during operation.
Place IPC below the product outlet chute.
Tie one end of the cloth below to the open end of the discharge chute of the sifter and the other end to the container placed below the discharge chute.
Ensure proper bellows fixed between PTS and sifter opening and charge the material to be sifted through PTS into the sifter.
Ensure earthing connection before start of sifting process.
Ensure that the powder containment booth is started properly and switch ‘ON’.
Switch on the sifter and open the butterfly valve of the IPC to regulate the flow of the material to be sifted.
After completion of sifting of the material, switch off the sifter, check for any material remaining in the IPC, and if there are any remanent sift the material as mentioned above.
Check for any material remaining on the sieve and in the table frame through the inspection windows provided, and if there are any remanent sift the material as mentioned above.
Remove the IPC containing sifted material by removing the cloth below tied to the discharge chute of sifter.
Remove the lid of the sifter and collect the retention if any in separate labelled polybag.
Dismantle the sieve and check its integrity and enter the details in the BMR.
Repeat the above procedure for remaining material.
After completion of the sifting of the batch material, switch off the mains and update the status label as “TO BE CLEANED”.
Record the operation of the machine in the Equipment Log Sheet.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PTS | : | Powder transfer system |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch Manufacturing Record |
| BPR | : | Batch Packing Record |
| MFR | : | Master Formula Record |
| QA | : | Quality Assurance |
| QC | : | Quality Control |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/operation-of-vibro-energy-sifter/
The procedure for operating the Vibro energy sifter seems quite detailed and well-structured, which is essential for maintaining quality in pharmaceutical manufacturing. I appreciate the emphasis on hygiene and compliance with industry standards, as these are critical in drug production. However, I’m curious about how often the sieve size needs to be checked for correctness—is it before every use or at specific intervals? The use of stainless steel for the sifter is a great choice, but are there any specific cleaning agents recommended to ensure no residue is left behind? I also wonder if there’s a backup plan in case the sifter malfunctions during operation—how is that typically handled? Overall, it’s impressive how this equipment ensures product consistency, but do you think there’s room for further automation to reduce manual intervention? What’s your take on the balance between manual checks and automated processes in this context?