Record the distance of the mechanical rod for six times from the highest point to the lowest point on both the sides.The acceptance criteria: 29 to 32 cycles / min. Record the frequency of mechanical rod for six times on both the sides.Record the usage entry of disintegration test apparatus in instrument usage log book.Complete disintegration is defined as that state in which any residue of the unit, except fragments insoluble coating or capsule shell, remaining on the screen of the test apparatus of surface of the discs, if used, is a soft mass having no palpably firm core.
NOTE: Disintegration does not imply complete dissolution of the unit or even of its active constituent. Observe the tablet manually after complete disintegration of tablet.Put Tablet in each cylinder & Press Enter.Press Enter –Instrument will stop at home position.
At ready condition Instrument will give beep sound. of tablet in Beaker A & Beaker B respectively & Press Enter Key. Select 3 rd option for both beaker in “Beaker selection.” Enter ID No. Prepare method with required temperature and time. At ready condition (set + 2☌ as per USP) it will give beep, put external RTD in both beaker and check the temperature. Instrument will start heating & on Display it will give temperature of beaker A, Beaker B & Bath. In “Function” mode select “Validation” & Enter media temperature 37☌ and bath temperature 38☌, Enter No. Check bath temperature on display & check the same with external RTDs. Hang the basket racks on the basket arm. Fill the beakers (1000ml) approx.700 ml with required buffer & put in to the water bath. Fill the bath with fresh water upto the water level mark. Follow this procedure to set the temperature of water bath. Check the RESET key and check the system Resets and initializes to home position. Initialization & System Diagnostics system initializes to home position and check LCD displays status. Place the external probe in the slot provided in both of the basket assemblies. Mesh of the basket is at highest point is at least 15 mm below the surface of the liquid. Adjust the volume of the liquid in the beaker such that the wire Place two 1000 ml beakers containing the suitable liquid medium in space provided. Switch on the mains to the instrument and the power switch on the instrument (provided at the rear right hand side) after ensuring that the instrument set up is okay. While engaging or disengaging the basket assembly, do not apply excessive force. Ensure that the heater connected is not loosely connected. Do not put the mains `ON’ if there is no water in the tank up to the marked level or if the tank is empty. Connect the heater wire and external probe in the socket provided at the rear right hand side. Fill water tank up to marked level, and placed the Glass / borosil beaker. The Head of Quality Department or his designee shall be responsible and implementation of the SOP. Analyst / Section Head or his designee shall be responsible for follow the SOP. This SOP is applicable to Disintegration Tester Apparatus in Quality Control Department at manufacturing facility of XXX. The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Disintegration Tester Apparatus.
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