In-process Checks For Primary Packaging
(Blister / Strip Packing)
Record the temperature and relative humidity of the Packaging area.
Tablets and Capsules: The following defect /Issue to be sorted out before strip/blister sealing
Broken Tablets
Laminated Tablets
Chipped Tablets
Discoloured Tablets
With Black particles Tablets
With foreign particle Tablets
Distorted Tablets
Foil shifting: Foil shifting reduces the sealing width of strips and to be observed carefully.
Batch coding details on foil:
Collect the number of strips equivalent to the no. of stereos of the overprinting roller, so that strips having batch details from all the different stereos are obtained. Check the batch details as per BPR.
Also observe the legibility of details, missing of letters, or smudging of ink.
Empty Pockets:
Check each pocket of the strip for the presence of a tablet/capsule.
Proper forming of blister:
The blister shall be fully formed as per the shape of the cavity of the forming roller. Each strip is to be carefully observed for any irregularity in the shape of blisters.
Proper cutting of the strips:
Examine the strips for proper cutting by measuring the sealing width on opposite sides of the strips and also observed any displacement of printed matter. Ideally the sealing width on the opposite sides of the strip should be equal.
Appearance of the strip: Check the strips
For poor knurling,
Delamination,
hologram creasing on foil and
Faulty printing such as ink lining; ink patches and poor legibility of printed letters.
Strip size:
Measure the length and width of the strip and verify the results with the values given in the packaging technical directions.
Leak test: perform a leak test as per the approved procedure.
In-process Checks during Secondary Packaging Operations
Performed in In-process quality checks as predefined frequency in BPR and to be sorted out the strips/blister with below mentioned tablet defects before packed in carton or during Packing
Broken Tablets
Laminated Tablets
Chipped Tablets
Discoloured Tablets
With Black particles Tablets
With foreign particle Tablets
Distorted Tablets
Improper Batch coding details on Strips/Blisters
Legibility of Batch coding details on strips, missing of letters or smudging of ink.
of Empty Pockets.
Proper forming of blister – any irregularity in the shape of blisters
Proper cutting of the strips/Blister
Appearance of the strip: Check the strips/Blister
For poor knurling,
Hologram creasing on foil and
Faulty printing such as ink lining; ink patches and poor legibility of printed letters.
Numbers of strips in one carton/cache cover as per required pack size:
Check each carton or cache cover for the total number of strips and verify the results with pack size mentioned in the Batch packaging Record.
Number of unit cartons in one multicarton as per required pack size:
Count the number of unit cartons in one multi-carton and verify with the pack size mentioned in the technical directions, packaging and outer carton.
Presence of package insert/ Patient information leaflets:
Before final closing of carton / unit cartons ensure the presence of package insert in each carton / unit carton, wherever applicable.
Proper insertion of tuck-in flaps:
Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting flaps or not.
Proper gluing of side seam/bottom lock of carton/cache cover:
The sealing of side seam and lock bottom flaps of carton / cache cover should be intact and shall not show any opening.
Batch details on carton/ cache cover:
Check the batch details as per batch packaging record and also observe for legibility of letters, missing of letters or smudging of ink, etc
Proper sealing of polyolefin shrink-wrap film:
Check whether the shrink-wrapping is proper done and is properly tight.
Sampling
Finished goods, control samples& stability samples shall be collected& recorded
Weighing of Carton
Maximum and minimum range for Carton shall be set by weighing of 10 cartons and shall be recorded in Format.
In-process Checks during Tertiary Packaging Operations
of cartons/ shrink-wrapped units in one corrugated box / LDPE bag:
Count the no. of cartons / shrink-wrapped units in one corrugated box / LDPE bag and verify with the Batch Packing Record.
Stencil on corrugated boxes:
Check the stencil details on the corrugated boxes.
Insertion of Packer’s slip:
Check insertion of packer’s slip in corrugated boxes.
Pasting of BOPP tape:
Check the pasting of BOPP tape on corrugated box for peeling-off of tape or opening of seal.
Net weight and gross weight of corrugated box:
Check and record both net weight and gross weight of the packed corrugated box for export products, but on the other hand for domestic products, check and record, Tare weight of C. Box, Gross weight of C. Box and weight of contents in C.Box.
Weighing of Corrugated Box:
Weight of 10 individual corrugated boxes shall be recorded, from where the Average weight of the corrugated box as well as the Maximum and Minimum wt. of Individual corrugated box shall be recorded.
In-process Checks: Packaging of Liquid Oral
Inspect the filled and sealed bottles at the start and regular intervals for all in-process check parameters as per frequencies concerning Technical Directions of the product during primary, secondary, and tertiary packaging of Liquid orals given below. Record the observations in the form “In-process Checks- Liquid Orals” “Visual Inspection Record – (Liquid Orals) Empty Bottles” and “Visual Inspection Record – (Liquid Orals) Filled Bottles” , “Fill volume determination” attached in the BMR.
Primary Packaging
Visual Inspection of Empty Bottles: Record the observations in “Visual Inspection Record – (Liquid Orals) Empty Bottles”.
Washed and dried / substantially water-free bottles are put on the turntable of the conveyor belt. Put two checkers to constantly carry out the visual inspection of the bottles on the line at the visual inspection table. Both checkers are to be changed with fresh checkers every two hours.
The checker picks up the bottles in case of any doubt and inspects them against a white diffused light background in a properly lit area for any defect. The light passing from beneath the table also visually inspects the bases of bottles.
Visual Inspection of Filled Bottles: Record the observation in “Visual Inspection Record – (Liquid Orals) Filled Bottles.
Check the filled bottles for any visual defects like black particles, fibers, and cap sealing (Record in the BMR, type of rejection).
Depute checkers for the inspection and these checkers are to be changed with fresh checkers every two hours.
Collect the rejected bottles separately according to the type of rejection suitably labeled ‘REJECTION’
At the end of the batch or shift, the workmen shall do as follows:
Cap rejections: Re-open the sealing of the cap, put a new ROPP cap, and seal again.
Less Volume: Collect the whole solution and again refill the bottles after washing.
Suspension: Re-open all the bottles and drain the solution.
Solution/ Syrup: Re-open, collect the whole solution filter the solution through nylon cloth of # 160, and again refill the bottles after washing.
Record the results.
Fill volume determination:
Fill volume determination: Completely drain the sample units from the filled bottles of each nozzle of the filling machine into separate graduated and calibrated cylinders. Allow the filled bottles to drain for about 3 minutes by inverting these on the rim of each of the measuring cylinders. The capacity of the cylinder should be as close as possible to the volume of fill to be measured.
When free from air bubbles, measure the volume in each cylinder.
The volume obtained from each cylinder shall not be less than 100% of the standard average fill volume mentioned in the BMR.
Record the results.
Deliverable volume determination
Deliverable volume is the volume dispensed by the bottle or container while in use. For the determination of deliverable volume, select not fewer than 12 bottles and dry graduated cylinders of a rated capacity not exceeding two and a half times the volume to be measured.
Mix the contents of the bottles individually. Gently pour the contents of each bottle into a separate dry graduated cylinder, being careful to avoid the formation of bubbles and allowing them to drain for a period not to exceed 3 minutes.
When free from air bubbles, measure the volume of each mixture.
The average volume obtained from the 12 bottles shall not be less than 100% of the desired volume, and the volume of no bottle is less than 95%.
Record the results.
Sealing of ROPP caps:
Sealing is to be monitored carefully on 12 randomly taken samples, by rotating the seals slowly clockwise and anti-clockwise till it stops. It shall break the skirts easily when turned anti-clockwise but it shall not rotate when turned clockwise. This check is applicable for bottles with screwed on the neck.
Sealing of rubber closure and flip-off tear-down aluminum seals: It is to be checked by inverting the bottle and checking for any leakage. Any part of the flip seal shall not remain in a lifted position and the skirt of the seal shall grip the lower surface of the neck of the bottle properly. This check is applicable for bottles with vial-type necks.
As per, In-process checks of liquid orals any kind of leakage in bottles shall be checked as per the procedure defined in BMR.
Secondary Packaging
Batch details on cartons/labels: Check the batch details as per the batch packaging record and also observe for legibility of letters, missing letters smudging of ink, etc.
Proper gluing of side seam/bottom lock of carton: The sealing of the side seam and lock bottom flaps of the carton shall be intact and shall not show any opening.
Proper insertion of tuck-in flaps: Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting flaps or not.
Tunneling in labels: The labels shall stick to the bottle surface properly and there shall not be any edge lifting. Neither shall there be any piping or tunneling nor thereby deformation of text matter due to air entrapment.
Positioning of the labels: The positioning of the labels shall be proper and at the middle flat portion of the bottle body.
Positioning of the measuring cups: Measuring cups shall be properly placed on the caps of the bottles and shall not come out.
Proper shrink-wrapping of bottle and thermocol box: The shrink-wrapping of bottle and thermocol box shall be tight and without any wrinkle.
Proper lidding of LDPE barrel: The LDPE barrel shall be properly lidded so that the lid shall not come out.
Presence of packaging booklet/package insert: Ensure the presence of packaging booklet/package insert wherever applicable.
Tertiary Packaging
of cartons / shrink-packed units in one corrugated box as per technical directions, packaging: Count the no. of cartons / shrink-packed units in one corrugated box.
Stencil on corrugated boxes: Check the stencil details on the corrugated boxes.
Packer’s slip: Ensure the presence of the packer’s slip inside the shipper.
Pasting of BOPP tape: Check the pasting of BOPP tape on the corrugated box for peeling off of tape or opening of seal etc.
Net weight and gross weight of corrugated box: Check and record both the net weight and gross weight of the packed corrugated box for export products, but on the other hand for domestic products, check and record the tare weight of C. Box, Gross weight of C. Box and weight of contents in C. Box and record.
Finished goods, control samples& stability samples shall be collected& recorded in In-process quality checks.
The weight of 10 individual corrugated boxes shall be recorded, from where the Average weight of the corrugated box as well as the Maximum and Minimum wt. of Individual corrugated boxes shall be recorded.
In-process Checks: Gel / Cream / Ointment
Inspect the filled and sealed tubes at the start and at regular intervals for all in-process check parameters as per frequencies concerning the batch size of the product during primary, secondary and tertiary packaging of Gel / Cream / Ointment given below. Record observations in the form for Packaging Operations – Ointment / Gel / Cream attached in the BMR.
Primary Packaging
Fill weight determination of filled tubes
Take 10 empty tubes and weigh them to find out the average weight of a tube.
Then fill those 10 tubes from the nozzles of the filling machine.
Wipe every filled tube with a clean cloth to ensure that no trace of Gel/ Ointment remains on the surface of the tubes.
Weigh 10 tubes and record the average fill weight of the tubes in “Fill variation sheet – Liquid Orals”. The average fill weight should not be less or more than the limits specified in BMR.
Compare the net fill weight figure with standard mean fill weight to determine any over / under filled weight tubes and also determine the average fill weight from the determined net fill weights.
Fill weight uniformity of filled Tubes
Mark and weigh 10 empty tubes. Find out the weight of the empty tubes
Fill marked 10 tubes from the nozzles of filling machine weigh those marked tube individually and record the net fill weight of each tube.
Then compare the maximum net fill weight and minimum net fill weight with standard fill weight.
Record the net fill weight, maximum, minimum and average weight “Fill Variation Sheet – Liquid Orals”. Each fill weight should not be less or more than the limits specified in BMR.
Appearance of the filled and sealed tubes: Check the tubes for poor creasing on foil 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 tube.
Proper trimming of the filled and sealed tubes: Check the filled and sealed tubes for proper trimming and presence of flash materials.
Sealing of the tubes: Check whether the sealing of the filled tubes is proper or not. The sealed tubes shall not leak.
Overheating of sealant polyethylene: 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.
Batch details imprinted on the sealing area: Check the batch details as per batch packing record and also observe the legibility of details or missing of letters.
Loose capping of tubes: Check whether the capping of the tubes is proper or loose.
Secondary Packaging
Proper gluing of side seam of carton: The sealing of side seam carton shall be intact and shall not be showing any opening.
Presence of package insert & other materials like applicator, etc: Ensure the presence of package insert or other applicable material, wherever applicable.
Batch details on cartons: Check the batch details as per batch packaging record and also observe for legibility of letters, missing of letters or smudging of ink etc.
Proper insertion of tuck-in flaps: Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting flaps or not.
Proper sealing of polyolefin shrink-wrap film: Check before shrink-wrapping whether the polyolefin shrink-wrap film is properly sealed or not.
Tightness of shrink-wrapping: Check whether the shrink-wrapped units are tight or not. There shall not be any rattling of the cartons inside the shrink-wrapped unit.
Number of unit carton in one white duplex board carton / shrink wrapped unit as per TD Packaging. Count the number of unit carton in one white duplex board.
Tertiary Packaging
of shrink-wrapped / duplex board carton units, in one corrugated box as per technical directions, packaging: Count the no. of cartons in one corrugated box.
Stencil on corrugated boxes: Check the stencil details on the corrugated boxes.
Pasting of packer’s slip: Ensure the pasting of packer’s slip.
Pasting of BOPP tape: Check the pasting of BOPP tape on corrugated box for peeling-off of tape or opening of seal etc.
Net weight and gross weight of corrugated box: Check and record both net weight and gross weight of the packed corrugated box for export products, but on the other hand for domestic products, check and record, Tare weight of C. Box, Gross weight of C. Box & weight of contents in C. Box & record in “Packed Corrugated Box Weight Record”.
Finished goods, control samples& stability samples shall be collected& recorded in In-process quality checks.
Maximum and minimum range for check weigher shall be set by weighing of 20 tubes and shall be recorded.
In-process Checks of Bulk Packaging of Tablets / Capsules/Husk
Inspect the filled and sealed bottles 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 Tablets / Capsules/Husk (Bulk Packing) given below. Record observations in the form for “Bulk Packaging In-process Checks” attached in the BMR.
Primary Packaging
Cleanliness of Bottle: Clean the inside surface of bottle using filtered dried air in order to remove the foreign particles entrapped in the bottle.
Number of tablets / capsules/husk in one bottle: Check the number of tablets / capsules bulk packed in one bottle and record their observation. In case of Husk packing check the weight of husk in the container.
Sealing of LDPE Bag: Check the proper sealing of LDPE bag after packing of the products in it.
Presence of Silica Gel: Ensure the presence of Silica Gel inside the bottle wherever applicable.
The Sealing of tagger: Check the proper sealing of aluminium tagger on the neck of the bottle.
Proper capping of the bottle: Check the capping of bottle for tightly screwed on the neck or not.
Secondary Packaging
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.
Proper gluing of side seam/bottom lock of carton: The sealing of side seam and lock bottom flaps of carton shall be intact and shall not be showing any opening.
Proper insertion of tuck-in flaps: Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting flaps or not.
Tunneling in labels: The labels shall stick to the bottle surface properly and there shall not be any edge lifting. Neither shall there be any piping or tunneling and thereby deformation of text matters due to air entrapment.
Positioning of the labels: The positioning of the labels shall be proper and at the middle flat portion of the bottle body.
Presence of packaging booklet/package insert: Ensure the presence of packaging booklet/package insert wherever applicable.
Tertiary Packaging
Number of cartons / labeled bottles or containers in one corrugated box as per technical directions, packaging: Count the number of cartons/ bottles or containers in one corrugated box.
Stencil on corrugated boxes: Check the stencil details on the corrugated boxes.
Pasting of packer’s slip: Ensure correct pasting of packer’s slip.
Pasting of BOPP tape: Check the pasting of BOPP tape on corrugated box for peeling-off of tape or opening of seal etc.
Net weight and gross weight of corrugated box: Check and record both net weight and gross weight of the packed corrugated box for export products, but on the other hand for domestic products, check and record, Tare weight of C. Box, Gross weight of C. Box & weight of contents in C. Box & record in “Packed Corrugated Box Weight Record” .
Weight of 10 individual corrugated boxes shall be recorded, from where the Average weight of corrugated box as well as the Maximum and Minimum wt. of Individual corrugated box shall be recorded.