Home > Manufacturing process of Health Supplements/Nutraceuticals

Material Receipt and Storage: 

1. Ingredients are received and stored in an enclosed warehouse which has controlled temperature and humidity. The storage condition as recommended by manufacturer or compendium should be followed.
2. The sampling of the ingredients is done in a sampling booth within the warehouse which has a controlled environment. 

Health Supplements/Nutraceuticals Processing: 

1. The health supplement/ Nutraceuticals processing is carried out in an enclosed area which has a controlled environment.
2. The industry best practice for air quality and controlled environment in this area is ISO 8, temperature NMT 25 degrees Celsius and RH 60% +/- 5% or as per product manufacturing guidelines if there are some stringent conditions required.
3. The raw material/ ingredient/ packing material enter the process area through a double door air lock facility which is equipped with air curtains.
4. Dust control systems are employed during the mixing, sifting, blending, compression and coating operations to avoid any cross contamination.

Capsule processing: 

• Dispensing of raw material/ ingredients/ packing material– This is a check to assure the materials entering the manufacturing area for weighing/ quantity check are released as indicated on the batch sheet.

• Sifting/ Sieving is a simple and convenient technique of separating particles of different sizes. It is done to remove any kind of impurity like dust, foreign matter etc.

• Blending is the process of dry mixing of ingredients to get a uniform consistency of nutrients in the mix as claimed by the organisation. Time, temperature and the blending RPM are key parameters that are monitored. Different kind of blenders include Plough blender, Ribbon Blender, Bin Blender, Cone Blender and V Blender.

• The bulk material is checked for quality and then unloaded and transferred into silos.

• The next process is Encapsulation which is to carefully include the powder formulation in the capsule. In case of Liquid formulation ensure Banding after encapsulation.

• The capsules are polished and pass through a metal detector.

• Empty Capsule Sorter or Mini Capsule sorter can be provided to remove the empty capsules / damaged capsules before primary packaging.

• The primary packing material i.e., bottles are cleaned by filtered air. 

• The printed capsules are then inspected and filled in bottles followed by capping in a packing machine.

• The filled bottles are then labelled, coded and finally packed in secondary packaging and palletized and transferred to the warehouse. 

Powder/ Premix processing: 

• After raw material/ ingredients dispensing, sifting and blending operation as explained above, the powder bulk formulation is released after quality testing.
• The bulk formulation is again sieved and after passing through metal detector/ magnetic grills the bulk is loaded in Silos.
• The powder/ premix is then filled in primary containers, weighed, capped, coded and then packed in secondary packing material and palletized and transferred to warehouse.

Tablet processing: 

• After raw material/ ingredients/ packing material dispensing, sifting and blending operations as explained above, the bulk formulation is unloaded in Silos after quality release.

• Compression is a process of making the tablets by pressing the bulk formulation granules in a die with lower and upper punch. The basic principle behind the tablet compression machine is by hydraulic pressure across the dies. Compression is done in separate cubicles and compression machines are provided with effective dust control systems to avoid cross contamination.

• Tablets are then collected into clean and labelled containers after inspection for the next process of coating.

• Coating is a covering that is applied to the surface of the tablet. Coating is applied using polymers on tablets for organoleptic and protection purposes. Coating pans are supplied with filtered air for drying purposes.

• The coated tablets are then printed with edible grade colours and inspected for quality and passed through metal detector.

• The primary packing material i.e. bottles are cleaned by filtered air.

• The printed tablets are filled in bottles followed by capping, labelling, coding and final packing in secondary packaging, palletized and transferred to the warehouse.

Soft Gel Capsule processing: 

• After raw material/ ingredients/ packing material dispensing as explained above there are 2 parallel processes – Fill preparation and Gel Preparation. The fill preparation can be oil based and suspension based.

• In the Gel preparation all the raw material and ingredients are mixed and vacuum is applied across the equipment. The gel is then sieved for any foreign particles and transferred to the Encapsulation machine.

• Suspension based fill preparation – The suspension is first heated and then other ingredients are mixed and heated. The suspension is then sieved, cooled and then milled to get a homogenous suspension and screened and transferred to the Encapsulation machine.

• Oil based Fill preparation – All the raw material and ingredients are added in the oil and mixed. Nitrogen is then purged in the oil to avoid any oxidation and formulation is then transferred to the encapsulation machine.

• In the Encapsulation the formulation is included in the Soft Gel capsule.

• The primary packing material i.e. bottles are cleaned by filtered air.

• The Soft Gel capsules are then inspected, filled in bottles and capped. The filled bottles are then passed through the metal detector.

• The filled bottles are then labelled, coded and finally packed in secondary packaging and palletized and transferred to the warehouse. 

Liquid processing: 

• After raw material/ ingredients/packing material dispensing and sifting operations as explained above, the syrup/suspension/emulsion etc. Preparation is done in Silos.

• Active ingredients are added to the syrup and volume make up is done to get the final syrup formulation which is then filtered through appropriate sieve.

• The primary packing material i.e. bottles are cleaned and inspected.

• The final syrup formulation is then pass-through magnetic grill before filling in bottles followed by capping. The filled bottles undergo a final physical inspection.

• The filled bottels are then labelled, coded and finally packed in secondary packaging, palletized and transferred to the warehouse. 

Finished Goods Storage and Dispatch:

1. Finished Good are stored in an enclosed warehouse which has controlled temperature and humidity. Industry best practice for storage condition is temperature not more than 25 degrees Celsius and Relative Humidity not more that 65% or storage conditions established based on stability studies can be used.
2. The dispatch vehicle interior (including walls, floor and ceiling) should be inspected for general cleanliness, freedom from moisture, foreign materials, damage, pest infestation, objectionable odours or other forms of contamination.
3. The loading of the dispatch vehicle happens through a double door air lock.
4. Prior to distribution or dispatch of a given batch of a product, it shall be ensured that the batch has been duly tested, approved and released by the quality control personnel. Pre-dispatch inspection shall be performed on each consignment on a random basis to ensure that only the conforming goods are dispatched.

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