1. Injection Molding
2. Cannula manufacturing and Assembling
3. Suture Manufacturing
4. Gloves Packaging and Alcohol pad preparation
Manufacturing and packaging operations are carried out by properly qualified machineries followed by validated methods with full documentation at all stages of operations maintaining the regulation of cGMP, ISO:13485.
HVAC systems are used for conditioning, monitoring and supplying clean air to the working floors according to the ISO guideline and facilitated with coarse filter, medium filter, final filter and de humidifier to control dust particle and humidity. The change rooms are designed with hundred percent exhausts and production area is connected with air shower tunnel to remove adhering dust, fiber and hair. Desired temperature and humidity is maintained automatically through the system.
Training programs take place on a regular basis according to written plan. Personnel at all levels undergo general cGMP and Technical Training appropriate to perform their job satisfactorily.
• Injection Molding Section – production of components of medical devices for IV Cannula, IV Infusion Set, Blood Transfusion Set, Urine Drainage Bag, etc. These areas are fully covered by HVAC systems and Class-D area is maintained.
• Suture Manufacturing Section: The following steps are followed for the manufacturing of Suture, namely Thread Rewinding & Cutting, Needle Attachment at MAC workstation, in-process quality control is ensured by Knot Pull Test, Tensile Strength, Checking of Thread & Needle Diameter, Packaging of Suture in Aluminum Foil Pack and then Inner Envelope. Finally packed sutures are sterilized by Ethylene Oxide Gas, or Irradiation by Gamma Ray.
• Cannula Manufacturing Section: Steps of Cannula manufacturing, like- Cutting, Burr Removing, Shinning, Tapping, Grinding, Honing and acid, soap & water washing. To maintain the quality of needle various tests, like dimension check, bevel shape, needle penetration tests are performed.
• Assembling Section: This section involves the assembling of molded medical devices parts to semi finished and finished products. This section is equipped with manual and fully automated machine like Scalp Vein Set Assembling Machine, Hypodermic Needle Assembling Machine, 0.05ml AD (BCG) Syringe Automatic Assembling Machine, High Frequency Welding machine for Drain Bag & Urine Drainage Bag etc.
• Blister Film Making Section: This section is involved in production of Blister film for packing of Syringes, Hypodermic Needle etc.
• Gloves Manufacturing Section- production of sterile latex surgical gloves and non-sterile latex examination gloves.
• Alcohol Prep Pad Manufacturing Section- production of Alcohol Prep Pad.
• Engineering/Industrial Engineering – JHRML have an EHS (Environment Health Safety) policy in place for maintaining health safety and environmental protection, infrastructure maintenance, machinery and other maintenance for smooth production.
• Quality Assurance/Quality Control – JHRML have fully equipped Quality Control laboratories for maintaining quality laboratories in accordance with the ISO:13485.
• Plant HR/Administration – Support different units of the plant for HR related issues, general services, general logistics and administrative issues.
Design of the room and air-conditioning systems:
• Prevention of contamination of the product.
• Protection of the environment.
• Protection of people.
• Prevention of the ingress of vermin, insects, birds etc.
There are different environmental zones maintained within the manufacturing area.