Example SOP: Operating Neocota and Ganscoater Tablet Coaters

In short: This example SOP describes how production staff can prepare, run and unload two perforated-pan tablet coaters, Neocota and Ganscoater, in manual and automatic mode. Machine-specific control-panel steps are examples that must be checked against your own manufacturer’s manual. Coating parameters always come from the approved batch manufacturing record (BMR).

This is an illustrative template to adapt under your own quality system. Values marked example in-house criterion are site practice, not regulatory requirements.

1. Objective

To describe the operation of the Neocota and Ganscoater machines used for tablet coating in the coating area.

2. Scope

The SOP applies to the Neocota and Ganscoater coating machines in the coating area of the manufacturing facility.

3. Responsibility

• Officer or executive, Production: operates the machine as per this SOP and the BMR, and records the data.
• Head of Production: ensures the SOP is implemented and operators are trained.
• Quality Assurance: verifies line clearance and reviews the batch record.

4. Regulatory background

Equipment must be of suitable design, size and location for its use and for cleaning and maintenance (21 CFR 211.63). It must be cleaned and maintained at intervals that prevent contamination or malfunction, under written procedures covering responsibility, schedule, method, disassembly and reassembly, protection from contamination before use and a cleanliness check immediately before use, with records kept (21 CFR 211.67). Equipment qualification is covered in qualification stages for equipment, facilities, utilities and systems and installation qualification protocol and report. Cleaning of the coater and the link to cleaning validation: see SOP on cleaning validation.

All process parameters (inlet and exhaust temperature, pan speed, spray rate, atomising air pressure, gun distance) are validated, product-specific values taken from the approved BMR and not from this SOP.

5. Procedure: Neocota

5.1 Machine set-up

1. Confirm the machine and area are cleaned as per the cleaning SOP and the status label is correct.
2. Fill the scrubber tank with water, add antifoaming agent if specified, and record it.
3. Check that the pan is clean and dry, and that the emergency stop is released.
4. Obtain line clearance as per the line clearance SOP.
5. Spray guns: lubricate needle and needle washer only with food-grade silicone grease; fit the nozzle size specified in the BMR; fix the guns on the gun bar and connect solution and air tubing.
6. Connect the solution tubing to the suspension vessel, weigh the coating suspension as per the BMR and keep it under continuous stirring.

5.2 Interlock check before manual operation

Test the interlocks before use (this example check is performed at a frequency set by your own procedure).

During spray testing, keep the gun bar outside the pan and collect the spray in a polyethylene bag.

5.3 Spray rate check and manual mode

1. Set the mode switch to manual, release the emergency stop, and keep the gun bar outside the pan.
2. Set the BMR parameters: inlet air temperature, pan rpm, distance between guns, spray pattern, spray rate and atomising air pressure.
3. To set the spray rate, run the peristaltic pump at the low speed specified in the BMR, collect the spray from each gun for one minute, weigh it and add the values to get the cumulative rate.
4. With the gun bar inside, check that the pan outlet air pressure is negative to the inlet.
5. After loading the tablets, warm the bed to the BMR temperature (check with a thermometer), then pause heating.
6. Measure the average weight of 20 tablets and the other pre-coating attributes in the BMR (for example thickness, hardness, dimensions and disintegration time) and record them.
7. Fix the gun bar, record the gun-to-bed distance, start the inlet blower and pan.

5.4 Coating operation

1. Start spraying when exhaust temperature is within the BMR limits; if not, stop the pan, heat the bed and recheck.
2. Record the coating parameters in the BMR at the frequency it states, and keep the suspension stirred throughout.
3. After the suspension is finished, stop the pump and atomising air and dry the tablets as the BMR instructs.
4. Stop the pan, take the gun bar out and stop heating. Keep the exhaust blower and scrubber running during loading and unloading.
5. Repeat the post-coating checks listed in the BMR and record them.
6. Unload the tablets into a labelled container with double polyethylene bags, cool them for 30 minutes (example in-house criterion), then close the container. Stop the exhaust blower and scrubber pump after unloading.

5.5 Auto mode

The Neocota PLC panel uses function keys (F1 to F10) with menus for login, recipe selection, alarms and mimic display. Because key layouts differ by machine build and software version, this example gives the sequence only in outline; follow your manufacturer’s manual for the exact keys.

1. Set the selector to auto, release the emergency stop and switch the PLC on.
2. Log in with the personal credentials issued to the operator (a shared login is not acceptable under data integrity expectations).
3. Open recipe selection and choose or enter the recipe. Enter product name, batch number, inlet and exhaust temperature, pan rpm, process time and pump rpm as per the BMR, and set the high and low alarm limits for inlet, exhaust and pan rpm. Download the recipe.
4. Open the mimic screen, start the system, and set the atomising air pressure with the gun bar outside the pan, flushing the spray into a bag.
5. Load the tablets, inch the pan if needed, fit the gun bar, perform the pre-coating checks and start the system.
6. Start spraying when exhaust temperature or bed temperature reaches the BMR value, and record parameters at the stated frequency.
7. At the end stop the operation; the spray stops first and then the pan, inlet blower, exhaust blower and scrubber stop in sequence. Unload as in section 5.4, and log out.
8. Record use and cleaning in the equipment usage and cleaning log, and in the daily machine log.

6. Procedure: Ganscoater

6.1 Preparation

1. Confirm the machine is cleaned, the correct pan (850 mm or 600 mm) is fitted, the scrubber sump water level is correct, the pan is clean and dry, the status label is right and the emergency stop is released.
2. Switch on the control panel (MMI) and select the plant screen.
3. Recipe menu: to load a saved recipe enter its number and load; to delete one enter the number and press delete; to create a recipe enter the name and number, then enter motor, general and temperature parameters as per the BMR and save. Protect the recipe against unauthorised change through the machine’s access-level system, not with a password written in the SOP.
4. Load the tablets (remove the spray bar, inch the pan if needed, refit the bar). Check atomising air pressure on the gauge against the BMR value.
5. Load the coating suspension into the feed chamber in the BMR quantity, open the outlet valve, fit the silicone tube in the peristaltic pump and check it moves freely, and assemble the spray guns, nozzles and air caps as per the BMR.

6.2 Auto mode

1. Select auto mode on the plant menu and start auto.
2. Check that the set parameters on the screen and the printout match the BMR.
3. Look through the view window to confirm uniform spray rate and pattern from each gun, no droplets falling on the bed and constant stirring of the suspension.
4. If adjustment is needed, pause dosing, correct the spray pattern or clean or replace air caps or nozzles, and resume.
5. Continue until the whole suspension is sprayed and finish as per the BMR.

6.3 Manual mode

1. Select manual mode. Enter pan speed with its allowed positive and negative deviation, dosing pump rpm, exhaust temperature, pre-jog and dosing inlet temperatures.
2. Enter general parameters: print interval, batch and lot number, recipe number and name, operator ID and product code; and pre-jog and post-jog cycles and the film or sugar coating mode.
3. Start in this order: scrubber, exhaust, inlet, pan; open the atomising valve and needle valve; start the dosing pump.
4. At the end reverse the order: dosing pump, needle valve, atomising valve, pan, inlet, exhaust, scrubber.

6.4 Unloading and report

1. Reduce pan rpm, take the spray bar out, and keep the scrubber, exhaust and pan running for about 10 minutes to cool the tablets (example in-house criterion).
2. Unload into a labelled stainless steel container with double polybag or an IPC with a single bag.
3. Print the set parameters from the reports menu.

7. Changing the coating pan

Changing between the 850 mm and 600 mm pan follows the same pattern: open the cabinet doors, place the mounting trolley under the supporting clamps, loosen and remove the fitted unit onto the standby platform, lift the other unit onto the trolley, align the flange, fit the bolts and tighten at once, remove the trolley, lock the inlet and exhaust plenums and close the doors. Record the change in the equipment log.

8. Calibration and maintenance

• Calibrate the equipment and related gauges every six months (example in-house criterion).
• Check the airflow (CFM) of the inlet and exhaust blowers yearly (example in-house criterion).
• Calibration, preventive maintenance and cleaning records are kept at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, section 4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

Frequently asked questions

Where do coating parameters such as spray rate and inlet temperature come from?

From the approved BMR, based on development and process validation for that product. This SOP only describes how to operate the machine.

Why check the spray rate before coating?

Uniform spray from each gun helps to give even film thickness and weight gain across the batch.

Why are interlocks tested?

They prevent unsafe or damaging sequences, for example running the inlet blower with the exhaust off.

Is a shared PLC login acceptable?

No. Each operator should use a personal login where the machine allows it, so entries are attributable.

Abbreviations

BMR: batch manufacturing record. PLC: programmable logic controller. MMI: man-machine interface. IPC: intermediate product container. rpm: revolutions per minute.

Training

Trainer: Head of Production or designee. Trainees: production staff.

References

1. US FDA, 21 CFR 211.63 Equipment design, size, and location; 211.67 Equipment cleaning and maintenance; 211.180(a) General requirements for records (eCFR).
2. EudraLex Volume 4, Part I, Chapter 4: Documentation, section 4.11.
3. Machine manufacturer’s operating manual for the installed Neocota and Ganscoater models (instrument-specific control-panel steps).
4. Site SOPs for equipment and area cleaning and usage records, line clearance and cleaning of the coaters.