OBJECTIVE:
To lay down the procedure for operation of automatic capsule filling machine (A 25).
SCOPE:
The Scope of this SOP is for operation of automatic capsule filling machine (A 25).
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 Automatic Capsule Filling Machine (A25) :
The Automatic Capsule Filling Machine (A25) is designed for efficient, high-speed capsule filling in pharmaceutical production. It automates the process of capsule separation, powder or pellet filling, capsule closing, and ejection. The machine begins by orienting and separating the empty capsules into the body and cap. The dosage material is precisely filled into the capsule bodies using a tamping or dosator system. After filling, the capsule caps are automatically aligned and locked onto the bodies. The filled capsules are then ejected for collection. The A25 ensures uniform dosing, high output, and minimal manual intervention, making it ideal for large-scale production.
PROCEDURE:
Check the cleanliness of the area and the machine.
Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the Co mill.
Check the room temperature and relative humidity.
Use cleaned scoops during the milling operation.
Check the required quantity of all the materials to be milled as per BMR.
SET-UP: Fixing of the Impeller and Screen:
Check the integrity of the impeller and screen.
Check the screen of the desired size.
Check the integrity of the gaskets.
Assemble the impeller and screen.
Secure the impeller assembly with retaining pins and mount the impeller in position by tightening the bolts.
Mount the desired screen on the screen holding plate and mount the holding plate on the two studs. Lock by rotating and clamp with wing nuts.
Check the alignment of screen on the holding plate; do not force the screen-holding plate on the studs.
Mount the discharge shroud.
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Operation:
Insert the power plug into the power supply socket and switch ON the mains.
Switch ON the main switch on the operating panel.
Press Co mill ON button on the operating panel.
Check that the machine is working properly.
Press Co mill OFF button on the operating panel.
Place the collection bin / container below the discharge shroud.
Press Co mill ON button on the operating panel.
Rotate the Pot knob and set the desired speed.
Charge the material gradually into the feed chute.
Feed the material at constant rate.
Collect the milled material into container and label accordingly.
After completion of the milling operation press Comill OFF button on the operating panel.
Switch OFF the main switch on the operating panel.
After ensuring that the machine is stopped, remove the screen and check for the integrity.
Affix “TO BE CLEANED” label after the completion of milling operation.
NOTE:
Do not overfeed the equipment as it may jam the impeller and damage the screen.
Do not operate the equipment without a screen, screen holding plate and discharge shroud in position.
Wait for the machine to stop fully.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Master Copy : Quality Assurance Department
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| QA | : | Quality Assurance |
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-automatic-capsule-filling-machine-a-25/
The Automatic Capsule Filling Machine (A25) seems to be a highly efficient piece of equipment for pharmaceutical production. I find it impressive how it automates the entire process, from capsule separation to filling and ejection, ensuring uniform dosing and high output. However, I wonder how often the machine requires maintenance to maintain its efficiency. Does the machine have any built-in mechanisms to alert operators when maintenance is needed? Additionally, the procedure for milling operation seems detailed, but I’m curious about the training required for operators to handle such precise tasks. Overall, it seems like a great asset for large-scale production, but I’d like to know more about its fail-safes to prevent errors or damage. Would you say the machine’s efficiency justifies its operational complexity?
The procedure for operating the automatic capsule filling machine (A25) seems quite detailed and well-structured. It’s impressive how the machine automates the entire process, from capsule separation to ejection, ensuring efficiency and precision. I wonder if there are any specific challenges or common issues that operators face during the operation of the A25. The emphasis on cleanliness and proper labeling is crucial, especially in pharmaceutical production. Do you think the machine’s high-speed operation ever compromises the accuracy of the dosage? Also, how often is the machine calibrated to maintain its performance? It would be interesting to know if there are any additional safety measures in place to prevent operator errors. Overall, the A25 appears to be a reliable solution for large-scale production, but I’m curious about its adaptability to different types of capsule materials. What’s your experience with this machine?