- OBJECTIVE:
- To lay down a procedure for the operation of Dissolution media preparatory.
- SCOPE:
This SOP is applicable to the procedure for the operation of Dissolution media preparatory at {Company Name} {Location}.
- RESPONSIBILITY:
- Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
- Head/Designee Quality Control – Shall be responsible for ensuring the compliance as per SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- Power on the instrument with the back side switch.
- Wait until the initialization is complete.
- Display indicates the current media availability and its temperature.
- If the media is available already press “Drain” button and put the nozzle into the waste container.
- Wait until the whole media is drained out.
- Press “Clean” button enter the volume, time, and temperature press enter key, put the nozzle in the media container”.
- Display indicates achieving set parameters and prompts to “park the nozzle in the holder to Prime” press OK.
- After the cleaning “Put the nozzle in the waste container”. The Cleaning solution will be drained out
- Press set key in the main menu enter the details of “volume” for aspiration.
- Select the Dispense and enter the dispensing temperature.
- Select the Degas and enter the temperature for degassing and also degas time.
- Press the start button and keep the nozzle in media container press F1 key to proceed.
- The run cycle will be completed and indicates “Achieving set parameters” After completion of run cycle Display prompts to press the Dispense key.
- Enter the dispense amount and keep the nozzle into the Jar, press Dispense button found on the nozzle.
- REFERENCES:
Not Applicable
- ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Quality Control
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| QC | : | Quality Control |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Frequently Asked Question?
1. What is the first step to power on the instrument?
Answer: Turn on the instrument using the back-side switch.
2. How do you know when the instrument is ready to use?
Answer: Wait until the initialization process is complete, and the display shows the current media availability and temperature.
3. How do you drain the existing media before cleaning?
Answer: Press the “Drain” button and place the nozzle in the waste container. Wait until all the media is drained out.
4. How do you set the cleaning parameters?
Answer: Press the “Clean” button, enter the desired volume, time, and temperature, and place the nozzle in the media container. Press “Enter” to confirm.
5. What happens after the cleaning cycle?
Answer: The display will indicate that the set parameters have been achieved and will prompt you to park the nozzle in the holder to prime. Press “OK” to start priming.
6. How do you dispose of the cleaning solution?
Answer: After priming, place the nozzle in the waste container, and the cleaning solution will automatically drain out.
7. How do you set up for aspiration and dispensing?
Answer: Enter the desired volume for aspiration in the main menu. Then, select Dispense and enter the dispensing temperature. Next, select Degas and enter the temperature and time for degassing. Finally, press the start button and keep the nozzle in the media container. Press F1 to proceed with the run cycle.
8. How do you dispense the media after the run cycle?
Answer: Once the run cycle is complete, the display will prompt you to press the Dispense key. Enter the desired dispense amount and keep the nozzle in the jar. Press the Dispense button located on the nozzle itself to start dispensing.