Capsule Manufacturing Flow in Pharmaceuticals

 

Capsule Manufacturing Flow in Pharmaceutical:

Dispensing of Raw materials:

Dispensing the right materials to the right batches prior to the manufacturing process is a key activity in life sciences and other process industries. The process is critical when working with potent active pharmaceutical ingredients (APIs) in drug manufacturing.

Dispensing of Intact Container – Raw Material

Write down the Gross weight, Net weight and Tare weight on material issue coupon. Gross weight shall be taken by weighing of the intact container, net weight. From the mother label of container and Tare weight by subtraction of net weight from the gross weight.

What is a dispensing area?

A Dispense Area represents the physical area in a warehouse where a dispensing activity occurs. The Dispensing Area can be divided into smaller rooms called Dispensing Booths which are the specific locations for dispensing activities.

What is weighing dispensing?

Weighing and dispensing activities are processes of transferring specific amounts of powder or liquid raw materials from the bulk container and into smaller units that will be dispensed in specific quantities for batch manufacture.

The Dispensing Process

Step One: Receive and Validate. As soon as you receive the Manufacturing Order, you need to validate it. ...

Step Two: Understanding the Manufacturing Order. ...

Step Three: Label and Prepare the Raw Materials. ...

Step Four: Final Check. ...

Step Five: Record Your Work. ...

Step Six: Delivery and Preparation of the next step Mixing.

Mixing:

After dispensing the raw materials transfers to mixing area.

Once materials received, the production department intimate QA to recheck and verify all materials, area of mixing and equipment’s used for mixing.

The QAI verify all parameters according to SOPs of the mixing area and then allows the production department to proceed the batch for mixing.

During mixing different machines are used for mixing of powders i.e Cube mixer, double cone mixer, v mixer or horizontal blade mixer.

When the powder become mix properly the production department intimate QA once again to collect the bulk sample from the mixer, QAI collects the sample with the help of zone sampler and submit the sample to QC department for the assay testing and analysis purpose. QC department analyze the sample by different techniques and methods with the help of UV, HPLC, UPLC, IR, FTIR etc.

When QC perform the test of sample with the stander and confirms the sample with label claim of the product then QC sent a release label which is signed by the Analyst and QC manager.

When production receives the release label or green slip of bulk release, it intimate the production department to prepare for the next step.

Capsule Filling:

Once the bulk release received from QC, the production department intimate QA department to inspect the capsule filling area.

QAI inspects all the parameters according to SOPs of capsule Filling area, they check the filling machine its clarity, the area, temperature and humidity etc. and allows the production department to proceed for the capsule filling.

Capsule Filling is either be on automatic capsule filling machine or semi-automatic capsule filling machine.

In-process checks:

During capsule Filling the QAi and production Pharmacist collect samples of filled capsule at different intervals and check the filled capsule with the sops of capsule filling to confirm either the capsules are filled correctly or not.

Polishing of filled capsules:

When the capsule filling process completed the production supervisor transfers the filled capsules for polishing, capsule polishing is done with the help of capsule polishing machine.

When all the capsules or batch becomes polished then the production proceed the batch for the next step blistering or directly packing in the jars.

 

Blistering:

After capsule polishing the polished filled capsules transfers to blistering section for blistering.

Blistering is the primary packing for filled capsule.

Blistering done with the help of different blistering machines.

Packing:

While blistering some industries having online packing system a conveyer belt is directly connected with the blistering machine, as the machine full the blister outside the conveyer belt moves the blister forward for further secondary packing. Where helpers checks the blister physical form, batch number and date of expiry on the blister.

And then these blisters are packed in unit carton with a folded leaflet.

Leaflet contain all the literature about the capsule presented in the blister, it contains all information about its dosage form, strength, indications, contraindications and adverse effects, Leaflet contain chemical formula also the company brand name.

In some industries the packing process is offline. Offline packing means that blistering is completed and all the blisters are transferred to packing hall at once, the packing in-charge distribute the blisters on conveyer belt manually and then start its final packing.

When the final packing get completed the production supervisor make a documented transfer of the whole batch and transfer it to dispatch section for marketing.