MAN-070 Example-IBC Operation and Cleaning

1. Dispensary to Staging Area

1.1.         It is the function of the Dispensary employees to correctly fill the IBC’s with raw material (i.e. bulk tablets) and to have the vessel correctly labelled and to contact the employees in Tablets area that the bins are ready for collection.

1.2.         A production schedule will be issued for Tablet production and a copy sent to the Dispensary as part of the communication required allowing the integration of work for the Dispensary to prepare before hand.  This tablet schedule will highlight the timing of the expected packaging operation, which implies that the dispensing of tablets will be required on the previous day at least.

1.3.         An authorised Tablets person will create a Material Transfer Order (Form-055) to allocate the tablets for the BPN.

1.4.         On completion of Dispensing and labelling by IBC Identification label (Form-380), the total quantity of IBC’s will be transferred to Tablet staging area. Once contacted that employee is responsible to arrange for collection of the IBC vessels.

1.5.         The authorised person collecting the vessel is to contact the Dispensary to confirm delivery and receipt of the IBC’s. Each vessel should be checked for the correct label identification and cleaning tag (Form-145). If it is not present the vessels should be returned directly to the Dispensary.

1.6.         These bins should be placed in the Staging area for the machine on which the tablets are going to be used.  The bin details (i.e. IBC ID Labels, IBC cleaning Tag) should be checked against the Transfer Order to confirm both the correct location and component.

2. Staging Area to Production

2.1.         When all components have been accounted for, and the production line is appropriately cleared, then the components including the IBC’s can be transferred to the Production bay.

2.2.         Movement of IBC’s can be either by pallet mover or manually relocated.

2.3.         The full IBC’s may be kept in the Staging area until such time as they are needed to be lifted on to the machine.

3. Cleaning of IBC

3.1.         Picture of an IBC:

3.2.         IBC lifter column needs to be used during the cleaning of IBC. The following IBC Internal surface locations require to be cleaned: IBC Internal walls, IBC Bottom cap, Top lid, Top lid “O”-ring, and IBC orifice cone.  The cleaning method of these areas is covered in the following sections.

SPECIAL NOTE 1:

Even if all the above parts may appear visibly clean, they must all be cleaned according to the following procedures as tablet active which cannot be seen can be present on the internal surfaces.

Ensure that all the cloths used to clean the above internal surfaces did not come in contact with the external surface of the IBC or any other equipment.  In such cases dispose of the cloth and repeat the cleaning procedure with a clean cloth.

SPECIAL NOTE 2:

Under no circumstances should an individual’s head enter the vessel.

3.3.         Start cleaning by remove the top lid and remove the plastic liner from inside.  Moisten a clean cloth with the 70% IPA.  Clean the Internal walls with the cloth.  After the IBC internal walls have been cleaned once, discard the cloth.  Apply a second clean cloth and repeat the above procedure.
Note: Use no less than two clean cloths to clean all the internal surfaces of the IBC.  Inspect all the Internal walls and ensure all visible traces of tablet residue are removed.

3.4.         Not all the Internal wall surfaces can be cleaned because some parts may be difficult to reach.  Obtain another clean cloth moistened with IPA and hand-wipe the top rim.  With the use of an IBC lifter lift it up to shoulder height.

Inspect the underneath side of the IBC where the bottom cap is installed and ensure that there are no tablets.  Clean the Bottom cap with a clean cloth moistened with IPA.  Repeat the above procedure with a second clean cloth.  Use no less than 2 clean cloths to clean this part.  Ensure all visible tablet residue is removed.  After it is cleaned, secure it to the vessel, finger tight only.

3.5.         Clean the Top lid, Top lid “O”-ring and IBC orifice cone with a clean lint-free cloth moistened with IPA.  Use no less than 2 clean cloths to clean all these parts.  Inspect all these parts for any signs of tablet residue.  Continue to clean these parts until all visual signs of tablet residue are removed.

3.6.         Clean all other External surfaces of the IBC with a lint free cloth moistened with IPA.  Once the cleaning is completed, clamp the lid to the vessel.

3.7.         Remove the tag or label containing the details of the previous contents.
Print out form Form-145, cut into individual tags.  Write IBC number, time IBC cleaning finished, sign and date and place a Yellow ‘Cleaning’ tag into the IBC identification pocket.
Note: Only print the forms as needed and throw away any unused tags – do not store for later use.

3.8.         Remove the IBC from the IBC lifter column and replace it with the next full IBC if required.  Continue with point 3.2 above.

3.9.         Returning IBC’s to Dispensary

3.10.      Prior to the completion on the batch, when the last IBC has been cleaned, contact Dispensary and advise them that the vessels are ready to be returned.

3.11.      At an agreed opportunity, deliver the vessels into the WIP area. This may take more than one delivery.

4. Summary of Changes