| In-Process Checks At Different Stage Of Packaging Operations |
1.0 OBJECTIVE: 1.1 To lay down a procedure for In-process checks at different stage of Packaging Operations. 2.0 SCOPE: 2.1 This procedure is applicable for the In-process checks at different stage of Packaging Operations. 3.0 RESPONSIBILITY: 3.1 Production and IPQA officer/supervisor are responsible for compliances as per the SOP. 3.2 Head Production and Quality Assurance are responsible for implementation. 4.0 PROCEDURE: Inspect the filled and sealed tubes/bottles/Containers at the start and at a regular interval for all in-process checks parameter as per frequencies with respect to batch size of the product during primary, secondary and tertiary packaging of concern area given below. Record the observations in the form for Packaging Operations In-process checks in the BPR and In process Sheet of concern Section. 4.1 In-Process Checks At Different Stage 4.1.1 Primary Packaging 4.1.1.1 Fill weight determination of filled tubes/bottles/Containers. Take 10 empty tubes/bottles/ Containers and weigh to find out the average weight of tubes/bottles/ Containers and mark all. Then fill those 10 marked tubes/bottles/Containers from the nozzles of the filling machine. Wipe every filled tube/bottle/ Container with a clean cloth to ensure that no trace of product remains on the surface of the tubes/bottles/ Containers. Weigh or volume 10 tubes/bottles/ Containers and record the average fill weight or volume of the tubes/bottles/ Containers in the BPR. The average fill weight/Volume should not be less or more than the limits specified in BPR. Compare the net fill weight figure with standard mean fill weight to determine any over/under filled weight tubes/bottles/ Containers and also determine the average fill weight/volume from the determined net fill weights/volume. The fill weight/volume must be checked at the start of filling and thereafter in every 30 minutes intervals or as recommended in the BPR. 4.1.1.2 Fill weight uniformity of filled tubes/bottles /Containers. Mark and weigh 10 empty tubes/bottles/Containers. Find out the weight of the empty tubes/bottles/ Containers. Fill marked 10 tubes/bottles/Containers from the nozzles of filling machine weigh those marked tubes/bottles/Containers individually and record the net fill weight/volume of each tubes/bottles/ Containers. Then compare the maximum net fill weight/volume and minimum net fill weight/volume with standard fill weight/volume. Record the net fill weight/volume, maximum, minimum and average weight/volume in the In-process Sheet of BPR. Each fill weight/Volume should not be less or more than the limits specified in BPR. The fill weight/volume variation to be done soon after the start of filling machine and thereafter in every 2 hours intervals or as recommended in the BPR. 4.1.1.3 Appearance of the filled and sealed tubes/bottles/Vials/Containers: Check the tubes/bottles/Containers for poor crease and also faulty printing such as ink lining; ink patches and poor legibility of printed letters. This check is meant to monitor the aesthetic appeal of the tubes/bottles/Vials/Containers. 4.1.1.4 Proper decoration of the filled and sealed tubes/bottles/Containers: Check the filled and sealed tubes for proper decoration and presence of flash materials. 4.1.1.5 Sealing of the tubes/bottles/Containers: Check whether the sealing of the filled tubes/bottles/Containers is proper or not. The sealed tubes/bottles/Vials/Containers shall not leak. 4.1.1.6 Overheating of sealant polyethylene (For Lemi Tubes): During tube sealing, care shall be taken and the sealing temperature shall be kept such that overheating of the sealing polyethylene is avoided. The evolving of waxy odour indicates burning or overheating of the sealing polyethylene layer in production department. 4.1.1.7 Batch details imprinted on the tubes/bottles/Containers: Check the batch details as per batch packing record and also observe the legibility of details or missing of letters. 4.1.1.8 Loose capping of tubes/bottles/Containers: Check whether the capping of the tubes/bottles/Containers is proper or loose. To read this SOP click here SOP for Cleaning of In process Stainless Steel items Used In Production. 4.1.2 Secondary Packaging 4.1.2.1 Proper gluing of side seam of carton: The sealing of side seam carton shall be intact and shall not be showing any opening. 4.1.2.2 Presence of package insert/ dropper: Ensure the presence of package insert/ dropper wherever applicable. 4.1.2.3 Batch details on cartons/labels: Check the batch details as per batch packaging record and also observe for legibility of letters, missing of letters or smudging of ink etc in production department. 4.1.2.4Proper insertion of tuck-in flaps: Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting. 4.1.2.5Tightness of shrink-wrapping: Check whether the shrink-wrapped units are tight or not. 4.1.3 Tertiary Packaging 4.1.3.1 No. of cartons in one corrugated box/ shipper: 4.1.3.2 Stencil on corrugated boxes. 4.1.3.3 Pasting of BOPP tape. 4.1.3.4 Net weight and gross weight of corrugated box. 4.1.3.5Follow the frequency as per the BPR or as prescribed in the following table. |
| In-process checks | Batch size of less than 10,000 tubes | Batch size of more than 10,000 tubes | Record as |
| Primary Packaging | |||
| Average fill weight/Volume | Continuous monitoring. Recording at the start/every 30 minutes | Continuous monitoring. Recording at the start/every one hour | OK/Not OK |
| Fill weight/Volume uniformity | OK/Not OK | ||
| Appearance of the filled and sealed tubes/bottles/Containers | OK/Not OK | ||
| In-process checks | Batch size of less than 10,000 tubes | Batch size of more than 10,000 tubes | Record as |
| Proper decoration of the filled and sealed tubes/bottles/Containers | OK/Not OK | ||
| Sealing of the tubes/bottles/Containers | OK/Not OK | ||
| Overheating of the sealant polyethylene (for lemi tubes) | Yes/No | ||
| Batch details imprinted on the tubes/bottles/Containers | OK/Not OK | ||
| Loose capping of tubes/bottles/Containers | Yes/No | ||
| Secondary Packaging | |||
Proper Gluing of Side Seam/Bottom lock of carton | Continuous monitoring. Recording at the start/every 30 minutes | OK/Not OK | |
| Presence of package insert/ dropper | Yes/No | ||
| Batch detail on cartons | OK/Not OK | ||
| Proper insertion of tuck-in flaps | OK/Not OK | ||
| Tertiary Packaging | |||
| No. of carton in one corrugated box as per BPR | Continuous monitoring. Recording at the start/every 30 minutes | OK/Not OK | |
| Stencil on the corrugated boxes | OK/Not OK | ||
| Pasting of BOPP Tape | OK/Not OK | ||
| Gross weight of packed corrugated boxes | Every shipper | Every shipper | Actual weight |
5.0 ABBREVIATIONS 5.1 SOP : Standard Operating Procedure 5.2 BPR : Batch Packing Record 5.3 IPQA : In-process Quality Assurance 5.4 LDPE : Low Density Poly Ethylene 5.5 BOPP : Bioxially Oriented Poly Propylene |