Medical Device Manufacturing Project for Reproductive Healthcare
Precision Manufacturing: IUDs, Oral Contraceptive Pills, Laparoscopic Devices – ISO 13485 & GMP Compliant
Manufacturing Capacity & Product Range
| Product | Annual Capacity |
|---|---|
| Copper T Intrauterine Device (IUD) | 15–20 Million Units/Year |
| Oral Contraceptive Pills (OCP) | 150+ Million Blister Packs/Year |
| Laparoscopic Tubal Ring Set | 100 Sets/Month (1,200 Sets/Year) |
Facility & Regulatory Compliance
Project Overview
The manufacturing facilities are designed and operated in accordance with ISO 13485 Quality Management Systems for Medical Devices, Good Manufacturing Practices (GMP), and applicable international regulatory requirements for reproductive healthcare products. The facilities support government family planning programmes, hospitals, NGOs and global healthcare organizations with high-quality contraceptive medical devices and pharmaceutical products for women's reproductive health.
Regulatory Compliance
- ISO 13485
- GMP Compliant
- Biocompatibility Testing
- Sterilization Validation
- Shelf-Life Studies
- Quality Management Systems
Copper T Intrauterine Device (IUD)
Product Description
Copper T is a long-acting reversible contraceptive device placed inside the uterus to prevent pregnancy for up to ten years. The device consists of a medical-grade polyethylene frame wound with high-purity copper wire and copper sleeves, providing effective contraception through controlled copper ion release.
Manufacturing Process
Raw Material Inspection & Testing
Medical-grade polyethylene, copper wire, polypropylene monofilament strings and packaging materials received with supplier certificates and undergo incoming quality inspection.
Polyethylene Frame Moulding
Medical-grade polyethylene frame manufactured by precision injection moulding under controlled conditions.
Copper Wire Winding
High-purity copper wire wound automatically around the vertical stem with copper sleeves fitted to the horizontal arms.
Retrieval Thread Attachment
Retrieval threads attached using validated assembly procedures to enable device removal when needed.
Dimensional & Visual Inspection
Each assembled device undergoes dimensional verification and comprehensive visual inspection for defects.
Ultrasonic Cleaning
Devices cleaned ultrasonically to remove any particulates or residues from assembly process.
Ethylene Oxide Sterilization
Validated ethylene oxide (EtO) sterilization process followed by aeration to remove residual sterilant.
Packaging & Release
Sterile IUDs sealed in medical-grade peelable pouches, packed into cartons and released after quality approval.
Laboratory Testing
| Raw Material Testing | In-Process Testing | Finished Product Testing |
|---|---|---|
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|
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Packaging
- Sterile medical-grade peel pouches
- Individual cartons with insertion instructions
- Bulk corrugated shipping cartons
- Complete labeling and batch identification
Critical Equipment
- Medical Injection Moulding Machines
- Copper Wire Winding Machines
- Automatic Assembly Stations
- Ultrasonic Cleaning System
- Precision Measuring Instruments
- Ethylene Oxide Sterilizer
- Aeration Chambers
- Cleanroom Assembly Equipment
- Automatic Pouch Sealing Machines
- Labeling and Cartoning Machines
Applications
- Long-term contraception
- Family planning programmes
- Postpartum contraception
- Government reproductive healthcare initiatives
- Private hospitals and gynaecology clinics
Oral Contraceptive Pills (OCP)
Product Description
Oral contraceptive tablets contain hormonal combinations used for effective birth control, menstrual regulation and reproductive healthcare. Tablets are supplied in calendar blister packs to ensure patient compliance and ease of use.
Manufacturing Process
Raw Material Dispensing
Pharmaceutical-grade active ingredients and excipients received and tested before dispensing in controlled environment.
Blending
Ingredients blended in high-shear mixers to ensure uniform distribution of hormonal components.
Granulation
Wet or dry granulation process depending on formulation to improve flow properties and compressibility.
Drying
Granules dried in fluid bed dryers to achieve required moisture content and stability.
Milling & Blending
Dried granules milled and blended before compression to ensure uniformity and consistency.
Tablet Compression
Blended material compressed into tablets using validated tablet compression machines.
Film Coating
Compressed tablets may be film-coated for improved stability, appearance and ease of identification.
Blister Packing & Cartoning
Tablets transferred to high-speed blister packing machines, packed into calendar blisters, batch coded and cartoned.
Laboratory Testing
| Raw Material Testing | In-Process Testing | Finished Product Testing |
|---|---|---|
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Packaging
- Calendar blister packs for compliance
- Printed cartons with product information
- Patient information leaflet
- Tamper-evident packaging
Critical Equipment
- Dispensing Booths
- High Shear Granulator
- Fluid Bed Dryer
- Multi Mill
- Bin Blender
- Tablet Compression Machine
- Film Coating Machine
- Metal Detector
- Blister Packing Machine
- Cartoning Machine
Applications
- Prevention of pregnancy
- Hormonal regulation
- Menstrual cycle management
- Public health and family planning programmes
Laparoscopic Tubal Ring Set
Product Description
The laparoscopic tubal ring system is a minimally invasive surgical device used for permanent female sterilization. Silicone rings are applied to the fallopian tubes during laparoscopic surgery, providing an effective method of permanent contraception with minimal tissue damage and rapid patient recovery.
Manufacturing Process
Silicone Ring Moulding
Medical-grade silicone rings moulded under controlled conditions using precision injection moulding.
Curing & Post-Curing
Moulded rings subjected to curing and post-curing processes to achieve required physical properties and biocompatibility.
Applicator Fabrication
Laparoscopic applicator components manufactured from high-grade stainless steel using precision CNC machining and polishing.
Component Assembly
Individual components assembled with rings and applicators calibrated for functional compatibility.
Functional Testing
Assembled sets functionally tested to ensure proper operation and ring deployment capability.
Ultrasonic Cleaning
Complete sets cleaned ultrasonically to remove any residues before sterilization.
Ethylene Oxide Sterilization
Validated EtO sterilization of finished sets followed by proper aeration.
Sterile Packaging
Finished sets packed in sterile barrier systems and labelled for medical use with complete traceability.
Laboratory Testing
| Raw Material Testing | In-Process Testing | Finished Product Testing |
|---|---|---|
|
|
|
Packaging
- Sterile medical pouches
- Protective trays
- Individual cartons with surgical instructions
- Corrugated shipping boxes
Critical Equipment
- Silicone Injection Moulding Machine
- Precision CNC Machines
- Surface Polishing Equipment
- Ultrasonic Cleaning System
- Assembly Fixtures
- Calibration Equipment
- Ethylene Oxide Sterilizer
- Sterile Packaging Line
Applications
- Permanent female sterilization
- Family planning surgery
- Government sterilization programmes
- Public and private hospitals
- Minimally invasive laparoscopic procedures
Facility & Equipment Capabilities
Facility Infrastructure
- ISO Class cleanrooms for medical device assembly
- GMP-compliant pharmaceutical production areas
- HEPA-filtered HVAC systems
- Purified water systems
- Compressed air and vacuum utilities
- Ethylene oxide sterilization facilities
- Quality Control and Microbiology Laboratories
- Validation and Calibration Laboratories
- Automated packaging and labeling lines
- Warehouse and storage facilities
Utility Systems
- Classified Cleanrooms
- HVAC with HEPA Filtration
- Compressed Air System
- Vacuum System
- Electrical Power with DG Backup
- Purified Water System
- Ethylene Oxide Sterilization System
- Environmental Monitoring System
- Chilled Water System
- Dust Extraction System
Quality Assurance & Regulatory Standards
Quality Management Systems
- ISO 13485 Certified
- GMP Compliant
- Biocompatibility Validation
- Sterilization Validation (EtO)
- Process Validation
- Shelf-Life Studies
- Stability Testing
- Risk Management
Laboratory Capabilities
Chemical & Physical Testing
- Polymer and material identification
- Elemental analysis (copper, metals)
- Mechanical properties testing
- Dimensional verification
- Surface analysis
Biocompatibility & Safety
- Biocompatibility testing
- Cytotoxicity testing
- Sensitization testing
- Irritation testing
Microbiological Testing
- Sterility testing
- Bioburden testing
- Endotoxin testing
- Environmental monitoring
Integrated Reproductive Healthcare Solution
The manufacturing facilities for Copper T IUDs, Oral Contraceptive Pills, and Laparoscopic Tubal Ring Sets demonstrate integrated capabilities in precision medical device manufacturing and pharmaceutical production. With production capacities of 15–20 million IUDs annually, 150+ million OCP blister packs annually, and 1,200 Laparoscopic Tubal Ring Sets annually, the facilities support domestic and international markets through government family planning programmes, hospitals, NGOs and healthcare organizations. The combination of ISO 13485 certification, GMP compliance, validated sterilization processes, comprehensive laboratory testing, and regulatory expertise ensures safe, reliable and effective reproductive healthcare products for women's health globally.
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