| Quality |
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| Quality Control |
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| The QUALITY CONTROL DEPARTMENT performs testing of all incoming materials and finished goods, maintains the records of the orders received, the dispatch status. |
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| It has the total details of production. All documents pertaining to a batch are maintained in this file. |
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| All the chemicals, dyes and gelatin used along with their quantities, whether the tank is prepared for body or cap, the color, for which machine the tank is prepared, batch number, date when the tank is made, what is the quantity of cutting added, the amount of DM water added to gelatin. |
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| The batch number, product code number, charge number, transfer tank code number, for which machine the tank is prepared, whether the tank is prepared for body or cap, the color code number, the date and for which shift the tank should be used, time of preparation, the volume of the gel in lts., the time vaccum has been applied, required viscosity, supplied viscosity, temperature of transfer tank at the time of loading. |
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| Has all the above details along with details pertaining to the total amount of quantity required for the entire batch the consumed quantity, quantity of chemicals, dyes used, the charge number, the temperature of room, gel and viscosity. |
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| Details of machine number, the shift, the previous product and batch number, whether all the equipment is checked before starting this batch, has the record as for the temperatures that are maintained every ½ hour. |
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- Capsule manufacturing record:
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| The cap and body conditions/parameters along with the physical dimensions of the capsule. Holds the transfer tank details and quantity of capsules manufactured. |
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- Capsule length check sheet:
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| The length of the capsule is checked every 3 hours. |
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- Capsule machine log sheet:
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| This sheet is used for monitoring the manufacturing conditions of the machine; basically the operator monitors the mechanical condition of the machines. Gel viscosity sheets, Temperature sheets. In process quality checking reports. Specimen label. |
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| Quality control reports: |
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- Testing of raw materials:
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| Tests for gelatin. |
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- Microbial test for gelatin:
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- TBC or TMC: should be more than 50cfu/gm.
- E Coli: should be absent/10gm.
- Salmonella: should be absent/10gm.
- Pseudomonas: should be absent/10gm.
- Staphylococcus aureus: should be absent/10gm.
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- Test for other chemicals:
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- PVP (poly vinyl pyrrolidone): It is a binding agent.
- SLS (sodium lauryl sulphate): It is an surfactant.
- TiO2 (titanium dioxide): It is an opacefying agent.
- Colorants.
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- Tests for packing material:
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- Corrugated boxes: EPS (Extended Polystyrene Sheet) Poly bags.
- Self adhesive tape: 72mm in diameter, brown color.
- Nylon strapping: 11mm diameter, nurling should be good.
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- TBC or TMC: should not be more than 500cfu/gm .
- E Coli: should be absent.
- Salmonella: should be absent.
- Pseudomonas: should be absent.
- Staphyllococcus aureus: should be absent.
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| Storage Condition Of Capsules |
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| The Ideal storage conditions are a relative humidity of 40% - 65% and a temperature of 15ºC - 25ºC. If, however, SUNLOC hard gelatin capsules are stored in the closed containers in which they are dispatched, they can safely be kept in areas where the ambient temperature is 15ºC to 25ºC and the relative humidity 40% to 65%. Prolonged Storage in areas outside these conditions may cause the capsules to soften and lose their shape or to become difficult to separate, with the result that difficulties may be encountered during the filling operation. |
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| In order to prevent such difficulties arising, it is recommended that containers of capsules are not stored directly on the floor. They should also be stored away from radiators and direct sunlight. Storage close to potential sources of water damage should also be avoided. If these precautions for transportation and warehousing are observed, SUNLOC hard gelatin capsules will remain in good condition for several years. |
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| Packing & Dispatch |
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| The capsules from the QA department go to the Packing and Despatch department where they are packed in robust corrugated boxes with EPS boxes and are on the way to their destinations. |
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| Before the capsules are finally packed they undergo a final run for inspection to check for the presence of any foreign capsule. |
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| The capsules are packed in quantity as per the average weight. The capsules are packed into anti static bags and put into corrugated boxes packed with EPS. Before the antistatic bags are sealed the dispatch samples for each box are removed and sent to the QA department. The dispatch samples which come to the QA department are once again tested for moisture and disintegration time. The QA department sends these capsules to the QC where the microbial test are performed and the stability of the capsules are ascertained. |
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| Corrugated Boxes Ptd. |
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| Ply |
*EPS Box Size in mm. |
Box Size in mm. |
No. of Capsules in Lacs/Box |
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Without EPS |
Size of Capsules |
With EPS* |
Without EPS |
| 5 |
550x530x720 24 kg/m3 |
550x530x730 |
550x440x700 |
00 |
0.75 |
0.75 |
| OEL |
0.75 |
0.75 |
| 0 |
1.00 |
1.00 |
| 1 |
1.25 |
1.25 |
| 2 |
1.75 |
1.75 |
| 3 |
2.25 |
2.50 |
| 4 |
3.00 |
3.00 |
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| Corrugated Boxes Unptd.(For Small Qty.) |
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| The packing is done in antistatic polythene bags and sealed, boxes are sealed with self adhesive tape and nylon strips. The packing material change as per the modes of transport. If the transport is by an air conditioned truck then 5 ply corrugated boxes without 25 mm EPS is used. If the transport is by non air conditioned trucks or railways then 5 ply corrugated boxes with 25mm EPS is used. |
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 Exports: For exports, 5 ply-corrugated boxes with 25mm EPS is used. Exports are sent by either air or by sea. |
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| Labeling: Boxes are labeled, which has the details of the customer, the quantity in lacs, the size, the color, batch number, the manufacturing date, date of expiry, gross weight, net weight and the storage conditions. |
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| Once the goods are packed, they are shifted into the finished goods godown, which is duly ENVIRONMENTAL CONTROLLED with regard to temperature and humidity. |
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| Transportation |
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| Care must be taken during transportation so that the boxed capsules do not get exposed to heat, e.g. at an airport tarmac or at truck depots. |
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| An exhaustive study was undertaken to study peak atmospheric conditions and their effects on capsules. Also each customer complaint on heat damage was critically analyzed. |
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| It was observed that in 95% of the cases, capsules were heat damaged due to : |
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| The capsules boxes lying at the airport tarmac under the hot sun. |
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| The capsules boxes being transported by non insulated vans. |
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| The capsules boxes lying with customer's transporter for 2-3 days in non controlled and reaching the customer on the fourth or fifth day instead of within 24 hrs. |
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| Hence it was decided by SHL that for domestic market the capsules will be transported by SHL's transporter in Reefer Vans by door to door delivery at an affordable cost. |
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| Shelf Life : The Shelf Life of our EHGC is 5 years from the date of manufacture. |
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