Pharmaceutical Formulation Manufacturing Project
Industry: Pharmaceutical Formulation Manufacturing
Products and Manufacturing Capacity
ORS
Product Description
Oral Rehydration Therapy (ORT) formulation used for the prevention and treatment of dehydration caused by diarrhoea, vomiting, excessive sweating and heat-related illnesses. The formulation replenishes water, sodium, potassium, chloride and glucose, restoring electrolyte balance in the body.
Manufacturing Process
Manufacturing begins with the receipt and quality testing of pharmaceutical-grade Sodium Chloride, Potassium Chloride, Sodium Citrate and Dextrose.
After approval, raw materials are accurately weighed and transferred into a stainless-steel ribbon blender where homogeneous dry mixing is carried out under controlled environmental conditions. Uniformity of blend is continuously monitored to ensure that every sachet contains the correct electrolyte composition.
The blended powder is passed through vibratory sieves and metal detectors before automatic sachet filling. High-speed Form-Fill-Seal machines produce moisture-proof laminated sachets with accurate weight control, followed by heat sealing, batch coding and cartooning.
Critical Equipment
- Stainless Steel Ribbon Blender
- Vibro Sifter
- Weighing Systems
- Dust Extraction System
- Metal Detector
- Automatic Sachet Form-Fill-Seal Machines
- Heat Sealers
- Batch Coding Machines
- Cartoning Machines
- Palletizing System
Utilities
- HVAC with Humidity Control
- Purified Compressed Air
- Electrical Power with DG Backup
- Water Purification System
- Dust Collection System
- Environmental Monitoring System
Laboratory Testing
| Raw Materials | In-process | Finished Product |
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Packaging
- Triple Laminated Moisture-resistant Sachets
- Printed Cartons
- Corrugated Shipping Boxes
Each sachet carries batch number, manufacturing date, expiry date, storage conditions and dosage instructions.
Dusting Powder
Product Description
Dusting Powder is a medicated topical formulation used for the treatment and prevention of fungal skin infections, prickly heat, itching and excessive perspiration. The formulation provides antifungal protection while keeping the skin dry and comfortable.
Manufacturing Process
Pharmaceutical-grade talc, zinc oxide, starch and antifungal active ingredients are received and tested before processing.
The materials are weighed and transferred into ribbon blenders where controlled dry blending ensures uniform distribution of active pharmaceutical ingredients. The blended powder is sieved to remove agglomerates and improve flow properties.
The finished blend is transferred to automatic powder filling machines where HDPE containers are filled, capped, induction sealed and labelled under controlled conditions.
Critical Equipment
- Ribbon Blender
- Vibro Sifter
- Pulverizer
- Dust Collection System
- Powder Transfer System
- Automatic Powder Filling Machine
- Bottle Capping Machine
- Induction Sealer
- Labeling Machine
- Cartoning Machine
Utilities
- HVAC
- Compressed Air
- Electrical Power
- Dust Extraction System
- Environmental Monitoring
- Purified Water for Equipment Cleaning
Laboratory Testing
| Raw Materials | In-process | Finished Product |
|---|---|---|
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Packaging
- HDPE Powder Containers
- Screw Caps
- Induction Seal
- Printed Labels
- Cartons
Sterile Ophthalmic Solutions (Blow-Fill-Seal Technology)
Product Description
The sterile ophthalmic manufacturing facility produced eye drops using advanced Blow-Fill-Seal (BFS) aseptic technology. BFS technology integrates bottle formation, sterile filling and container sealing into a single continuous operation, minimizing contamination risks and ensuring sterility.
Manufacturing Process
Purified Water for Injection (WFI) is prepared and transferred into stainless-steel mixing vessels. Active pharmaceutical ingredients, preservatives and buffering agents are dissolved under controlled conditions.
The solution is filtered through progressively finer filters followed by a 0.22-micron sterilizing membrane filter. The sterile solution is transferred directly to the BFS machine.
Within the BFS machine, pharmaceutical-grade LDPE resin is extruded into sterile containers, filled with sterile ophthalmic solution and hermetically sealed in one continuous operation under Class 100 (ISO 5) aseptic conditions.
Filled bottles undergo visual inspection, leak testing, labeling and packaging before release.
Critical Equipment
- WFI Generation System
- Stainless Steel Mixing Vessel
- Sterile Holding Tank
- 0.22 Micron Sterile Filters
- Blow-Fill-Seal Machine
- Laminar Air Flow Units
- HVAC System
- Clean Steam Generator
- Sterile Transfer System
- Automatic Inspection Machine
- Leak Testing Equipment
- Labeling Machine
- Cartoning Machine
Utilities
- Water for Injection (WFI)
- Clean Steam
- HVAC (Class 100 / ISO 5 Aseptic Areas)
- Chilled Water
- Compressed Sterile Air
- Nitrogen Supply (where required)
- Electrical Power with DG Backup
- Environmental Monitoring System
Laboratory Testing
| Raw Materials | In-process | Finished Product |
|---|---|---|
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Packaging
- LDPE Blow-Fill-Seal Bottles
- Tamper-evident Caps
- Printed Labels
- Unit Cartons
- Corrugated Transport Boxes
The BFS manufacturing process provides high sterility assurance, minimizes human intervention, extends product stability and ensures consistent pharmaceutical quality. The facility was designed in accordance with Good Manufacturing Practices (GMP) and stringent aseptic processing standards to produce safe, effective and reliable ophthalmic formulations.
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