OBJECTIVE:
To lay down a Procedure for operation of disintegration test apparatus.
SCOPE:
The scope of this SOP is for operation of disintegration test apparatus.
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 DT Apparatus
A disintegration test apparatus is a laboratory instrument used in pharmaceutical testing to determine the time it takes for tablets or capsules to break down into smaller particles under specified conditions. It consists of a basket-rack assembly holding six glass tubes, each containing a tablet, which is repeatedly raised and lowered in a beaker of water or suitable liquid maintained at 37°C. The apparatus simulates conditions in the gastrointestinal tract, ensuring that tablets disintegrate within the prescribed time for effective drug release. Accurate disintegration testing is crucial for quality control, regulatory compliance, and ensuring the safety and efficacy of oral medications.
OPERATION:
- Switch ON the mains.
- Press the START / STOP switch on the rear right hand side of the instrument base.
Mode Setting
Timer key is a toggle key to set Timer mode or Manual mode of operation. In case of Manual mode, the display shows ‘——’.
Incase of the Timer mode the apparatus is switched off automatically after the set time value of the test.
Incase of the manual mode the apparatus run irrespective of the set time value. Check that the water bath is filled up to the level marked and beakers filled with freshly collected purified water and set the temperature in the following procedure.
Press “SET” Key.
Press “TEMP.” Key.
Press “DISP. SEL” Key to select the digit to be changed.
Press either “∆” or “∇” Key to attain the desired temperature.
Press “ENTER” Key to set the temperature.
The “TEMP.” key is a toggle key used to start and stop the temperature controller.
Set the time in the following procedure:
Select the timer in MIN: SEC range by pressing the key SET, ENTER simultaneously. Incase of HRS: MIN the display shows a “-” before time.
Press “SET” Key.
Press “TIMER” Key.
Press “DISP. SEL” Key to select the digit to be changed.
Press either “∆” or “∇”key to attain the desired temperature.
Press “ENTER” Key to set the timer.
“START / STOP” key is toggle key for the timer.
After completing the parameter settings start the temperature controller by pressing “TEMP.” key.
Select the bath temperature indicator using PROBE / SEL key. Once the bath temperature achieves the set value the instrument is ready to use.
PRECAUTION:
The external probe should be handled carefully. When the external probe is not in use, keep it in the place provided for it in the bath.
Press the START / STOP key to start the test.
Take sufficient quantity of tablets / capsules to be tested as per the BMR specifications.
Place one tablet / capsule in each cylinder of the basket followed by disc.
Place the disc on each tablet/Capsule with pointed end facing downward direction.
In case of tablets assume instrument, right side basket is to load RHS tablets and left side basket is to load LHS tablets of compression machine.
For single rotary compression machines, collect the tablets and perform the test by using any one basket in disintegration test apparatus.
Observe the tablet / capsule to disintegrate completely through the mesh.
Observe the tablet / capsule to disintegrate completely through the mesh.
Record the time shown in the timer in BMR.
Remove the basket assembly and hold it on top to the beaker, so that the traces of water fall into the beaker.
Use suitable forceps for removing disc from basket, wipe it with lint free cloth and place the discs in the disc box.
Replace the water in the beaker before proceeding for the next test.
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
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/operation-of-disintegration-test-apparatus/
ABBREVIATIONS:
| HDPE | : | : High density polyethylene |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch Manufacturing Record |
| LHS | : | Left hand side |
| QA | : | Quality Assurance |
| RHS | : | Right hand side |
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-disintegration-test-apparatus/
The procedure for operating the disintegration test apparatus seems quite detailed and essential for ensuring accurate pharmaceutical testing. It’s impressive how the apparatus simulates gastrointestinal conditions to guarantee effective drug release. However, I wonder if there are any common challenges faced during this process, especially with maintaining the precise temperature required. The toggle keys for timer and temperature control appear straightforward, but could initial setup mistakes lead to significant errors in results? Also, it’s crucial that the water bath and beakers are prepared correctly – how often are these steps double-checked to avoid inconsistencies? Overall, this SOP highlights the meticulous nature of pharmaceutical quality control, but I’m curious if there’s any room for human error in this seemingly automated process. Would you say this method is foolproof, or are there any known limitations or improvements being considered for this procedure?