SOP for Pharmacology

1.0 OBJECTIVE:

To lay out the steps for running and caring for pharmacology lab equipment. This guide helps staff use machines the right way. It also covers how to clean and check equipment before and after each use.

2.0 SCOPE:

This SOP covers all equipment in the pharmacology lab. This includes dissolution testers, disintegration units, hardness testers, friability drums, and balances. It also applies to any other tools used to test drug products.

3.0 RESPONSIBILITY:

Lab Technician & QC Analyst.

4.0 ACCOUNTABILITY:

QC Manager & Pharmacology Department Head.

5.0 PROCEDURE:

5.1 Check that the work area is clean. Look at each piece of equipment. Make sure the “CLEANED” tag is in place before you start.

5.2 Write down your name, the date, and time in the Equipment Usage Log. Also note the batch number you will test.

5.3 Take off the “CLEANED” tag. Put on the “UNDER PROCESS” tag.

5.4 Get a Line Clearance form from QA. Do not start work until you have this form signed.

5.5 Precautions:

5.5.1 Keep all guards and covers in place when the machine runs. Do not run equipment with covers open or removed.

5.5.2 Never bypass safety switches. They are there to protect you.

5.5.3 Do not change or modify any machine without written approval. This includes adding or removing parts.

5.5.4 Never try to fix, clean, or oil moving parts while the machine is on. Turn it off first.

5.5.5 Switch off the main power during setup, breakdown, cleaning, and repairs. Unplug the cord if you can.

5.5.6 Do not turn off or disable safety devices. If one breaks, report it right away.

5.5.7 Wipe down surfaces and control panels with a soft dry cloth. Do not use rough pads or strong chemicals.

5.5.8 Wear your PPE at all times. This means lab coat, gloves, and safety glasses.

5.5.9 Do these safety checks once a week:

5.5.9.1 Test that you can cut main power with the power switch.

5.5.9.2 Press the emergency stop button. Make sure it stops the machine.

5.5.9.3 Open each safety door. The machine should stop when you do this.

5.5.9.4 Write down the results in the safety check log.

5.6 Dissolution Apparatus:

5.6.1 Setup:

5.6.1.1 Check that all vessels are clean and dry. Look for cracks or scratches. Do not use damaged vessels.

5.6.1.2 Place vessels in the water bath. Line them up with the paddle or basket shafts.

5.6.1.3 Set the paddle height. The gap between paddle and vessel bottom should be 25 mm. Use a ruler to check.

5.6.1.4 Fill the water bath with purified water up to the fill line.

5.6.1.5 Look at each paddle or basket. Check for rust or bent parts. Swap out any that look worn.

5.6.2 Temperature:

5.6.2.1 Set the bath to 37°C. Most tests need this temp.

5.6.2.2 Wait at least 30 minutes for the water to heat up. Do not rush this step.

5.6.2.3 Use a thermometer to double check. Write down what you see.

5.6.2.4 Watch the temp during the test. It should stay between 36.5°C and 37.5°C.

5.6.3 Running the Test:

5.6.3.1 Set the RPM based on your test method. Most use 50 or 100 RPM.

5.6.3.2 Check the speed with a tachometer. Do this at the start and end of each run.

5.6.3.3 Watch the paddles spin. They should turn smooth with no wobble.

5.6.3.4 Add the test medium to each vessel. Heat it to 37°C before you pour.

5.7 Disintegration Tester:

5.7.1 Setup:

5.7.1.1 Look at the basket rack. Check the wire mesh for holes or rust.

5.7.1.2 Count all six tubes. Make sure they are locked in place.

5.7.1.3 Add discs to the tubes if your test method calls for them.

5.7.1.4 Set the unit on a flat surface. Use a level if you have one.

5.7.2 Medium:

5.7.2.1 Fill the beaker with your test liquid. Most tests use water or fake stomach fluid.

5.7.2.2 Use enough liquid so the basket stays under water during the full stroke.

5.7.2.3 Heat the liquid to 37°C. Keep it there for the whole test.

5.7.3 Running the Test:

5.7.3.1 Drop one tablet or capsule in each tube. That’s six total.

5.7.3.2 Start the machine. The basket should move up and down about 55 mm each stroke.

5.7.3.3 The basket should cycle 29 to 32 times per minute. Count a few cycles to be sure.

5.7.3.4 Watch each tablet break apart. Write down the time when each one fully falls apart.

5.8 Hardness Tester:

5.8.1 Setup:

5.8.1.1 Turn on the tester. Let it warm up for 15 to 30 minutes.

5.8.1.2 Wipe the anvil and plunger clean. Remove any dust or old tablet bits.

5.8.1.3 Zero the display before you test. Do this for each new batch.

5.8.1.4 Look at the calibration sticker. Make sure the unit is still in date.

5.8.2 Testing:

5.8.2.1 Put a tablet flat on the anvil. Center it under the plunger.

5.8.2.2 Press the start button. The plunger will push down slowly until the tablet cracks.

5.8.2.3 Read the force on the screen. Write it down in Newtons or kiloponds.

5.8.2.4 Test at least 10 tablets. Then find the average.

5.9 Friability Tester:

5.9.1 Sample Prep:

5.9.1.1 Brush off any loose dust from your tablets. Use a soft brush or air jet.

5.9.1.2 Weigh the tablets on a balance. Write down the weight to three decimal places.

5.9.1.3 For small tablets (650 mg or less), use enough to make about 6.5 grams total.

5.9.1.4 For big tablets (over 650 mg), just use 10 tablets.

5.9.2 Running the Test:

5.9.2.1 Put the tablets in the drum. Close and lock the lid tight.

5.9.2.2 Set the drum to spin 100 times at 25 RPM. This takes 4 minutes.

5.9.2.3 When done, take out the tablets. Brush off the dust. Weigh them again.

5.9.2.4 Use this formula: % Loss = [(Start Weight – End Weight) / Start Weight] × 100.

5.9.2.5 The test passes if you lose less than 1% of the weight.

5.10 Analytical Balance:

5.10.1 Before You Weigh:

5.10.1.1 Put the balance on a stable bench. Keep it away from drafts and vents.

5.10.1.2 Check the bubble level. Turn the feet until the bubble sits in the center.

5.10.1.3 Turn on the balance. Wait 30 minutes before you use it.

5.10.1.4 Clean out the weighing pan. Make sure nothing is left from the last user.

5.10.2 Daily Check:

5.10.2.1 Test the balance each day with a known weight. Use a certified standard.

5.10.2.2 Write down what the balance shows. Compare it to the true weight.

5.10.2.3 If the reading is off by too much, stop and tell your supervisor.

5.11 Cleaning:

5.11.1 Clean all parts that touched your samples after each use.

5.11.2 Use only approved cleaning agents. Check the cleaning SOP for your equipment.

5.11.3 Rinse parts with purified water. Dry them fully before you put them away.

5.11.4 If you can’t clean right away, put a “TO BE CLEANED” tag on the machine.

5.11.5 Log all cleaning in the record book. Sign and date each entry.

5.12 After You Finish:

5.12.1 Turn off all machines. Let hot parts cool down.

5.12.2 Swap the “UNDER PROCESS” tag for a “CLEANED” tag once cleaning is done.

5.12.3 Fill out the usage log. Note the end time and any issues you saw.

5.12.4 Tell your supervisor right away if something broke or acted strange.

5.12.5 Put all loose parts back in their storage spots.

5.13 Capsule Polisher:

5.13.1 Setup:

5.13.1.1 Check the polishing brush. Look for worn or missing bristles. Swap it out if needed.

5.13.1.2 Make sure the dust collector bag is empty. A full bag slows down the machine.

5.13.1.3 Set the machine on a flat surface near a power outlet.

5.13.2 Running:

5.13.2.1 Pour capsules into the feed hopper. Do not overfill past the max line.

5.13.2.2 Turn on the unit. Capsules will move through the brush and come out clean.

5.13.2.3 Check the first few capsules. They should be shiny with no powder on them.

5.13.2.4 Empty the dust bag when the batch is done. Wipe down the hopper and chute.

5.14 Tablet Counter:

5.14.1 Setup:

5.14.1.1 Pick the right size tray for your tablets. Small tablets need small holes.

5.14.1.2 Set the batch count on the display. This tells the machine when to stop.

5.14.1.3 Place a clean container under the chute to catch the counted tablets.

5.14.2 Running:

5.14.2.1 Load tablets into the hopper. Spread them out so they don’t jam.

5.14.2.2 Press start. The tray will shake and tablets will drop through the holes.

5.14.2.3 The sensor counts each tablet as it falls. Watch the display to track progress.

5.14.2.4 When done, double check a few containers by hand. Make sure the count is right.

5.15 RECORDS:

5.15.1 Equipment Usage Log Book.

5.15.2 Calibration Log.

5.15.3 Cleaning Record.

5.15.4 Maintenance Log Book.

5.15.5 Breakdown and Repair Log.

6.0 ABBREVIATIONS:

6.1 SOP: Standard Operating Procedure.

6.2 QC: Quality Control.

6.3 QA: Quality Assurance.

6.4 USP: United States Pharmacopeia.

6.5 RPM: Revolutions Per Minute.

6.6 PPE: Personal Protective Equipment.

6.7 IP: Indian Pharmacopoeia.

6.8 BP: British Pharmacopoeia.