Production of Health Supplements and Nutraceuticals

Manufacturing requirements for Tablets & Capsules

Manufacture of Dosage forms (Tables and Capsules):

Dust control system shall be employed while processing of dry materials to avoid any cross contamination.

A process of line clearance shall be implemented before various processes like dispensing, mixing, sieving, blending, compression and packing.

All raw material and ingredients shall be tested and released prior to dispensing as per BOM (Bill of Material). All ingredients for dry product shall be shifted before use. All materials shall be protected from metal, wood, plastics and other foreign particles.

Air conditioning shall be provided to avoid any cross contamination during processing.

There should be no evidence of lubricants leaking into the product from any part of the equipment. As a good manufacturing practice food grade lubricant should be used where possibility of incidental contact exists. Air extraction nozzles of compressed air are to be kept clean. Air entering the driers shall be filtered. Filters shall be installed in air extraction systems with discharge points to retain dust and protect the factory and local environment.

Screens, sieves, punches and dies shall be examined for wear and tear or for breakage before and after each use.

Differential pressure between rooms shall be regularly monitored and any deviation shall be brought to the immediate attention of the production and Quality Assurance Department. The maximum period of storage of the bulk materials shall be validated and specified.

Shifting, Mixing, Blending and Granulation:

The integrity of sieves before and after the process has to be ensured. Residues from sieving operations shall be examined periodically for evidence of the presence of unwanted materials. Sieves and screens in the sieving equipments should be free from lead.

Filter bags fitted to fluid-bed drier shall not be used for different products, without being washed in between use.

With certain highly potent or sensitizing products, bags specific to one product only shall be used.

Blending time and RPM shall be recorded in manufacturing record. Sifting and blending equipment’s shall be fitted with dust extractors or air handling unit for control of dust.

Mixing time, temperature and ampere load and other key parameters shall be recorded in the batch manufacturing record.

Compression of tablets:

Tablets from each compression station are to be inspected at fixed intervals for pharmacopeia parameters like appearance, weight variation, disintegration, hardness, friability, thickness and contamination by lubricating oil. The results shall be recorded in the batch manufacturing record. Each compression machine shall be installed in separate cubicles, within its own enclosed air-controlled environment. Tablets shall be collected into clean, labelled containers. Tablets shall be de-dusted and monitored for the presence of foreign materials besides any other defects.

Weighing equipment’s shall be calibrated for in-process monitoring of tablet weight variation.

Labelling shall be done of all the in-process material, granules and tablets to prevent any mix up during compression process.

In-process control shall be employed to ensure that the products remain within specification. Procedures shall be in place for detecting out-of-limit tablets. Rejected or discarded tablets shall be isolated in identified containers and their quality recorded in the Batch Manufacturing Record.

Coating of Tablets:

The preparation and use of coating solution shall be documented and recorded. The Coating solution shall be freshly made to minimize the risk of microbial growth.

Air supplied to coating pans for drying purposes shall be filtered air and of suitable quality. The area shall be provided with suitable exhaust and environmental control (temperature, humidity) measures.

Encapsulation – capsules (Power & Liquid Filled):

Capsules shall be stored under adequate environmental conditions ensuring safety from the effects of excessive heat and moisture.

Industry best practices for environment conditions of this area are temperature not more than 25 degrees Celsius and RH not more than 60+/- 5% as per the product requirements.

Printing (Tablets and Capsules):

Tablets and capsules after printing shall only be released after approval from quality control.

Edible grade colours and suitable printing ink shall be used for such printing.

Special care shall be taken to avoid product mix-up during any printing of tables and capsules.

Where different products, or different batches of the same product, are printed simultaneously the operations shall adequately be segregated.

Packing of Tablets and Capsules:

Prior to commencement of any operation, an independent check of the packaging equipment is to be maintained. Packaging material shall be tested against laid down standards and released prior to dispensing.

Line clearance shall be done before dispensing of packing material and before a new packing operation starts. It is to be ensured that all tablets, capsules or foils of the previous batch are removed before a new packing operation starts.

Integrity of individual package shall be subjected to vacuum test or other suitable methodology, periodically to ensure leak proof seal integrity and records shall be maintained.

Uncoated table shall be packed on equipment designed to minimize the risk of cross-contamination. Such packing shall be carried out in an isolated area.

The package coming out of the machine shall be inspected for defects such as misprint, No-fill, Cuts on the foil, missing tablets and improper sealing.

Outdated or obsolete primary packaging material or printed packaging material shall be destroyed and recorded.

As industry best Practices, in-case tablets or capsules in the pack can’t be seen or counted after primary packing, the primary packaging machines for packaging of Tablets or Capsules should have no fill detectors, metal detectors and check wares to check for empty packets, metal contamination and broken tablets.

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