The name Harsoria™ derives from the ancestral village of the promoters, HARSORA. Harsora village is situated in Bansur sub-division of Alwar district in the state of Rajasthan (Latitude. 27.78°, Longitude. 76.45°). Promoters at Harsoria Healthcare Pvt. Ltd. continue to maintain relations with the Harsora village and community.

Factory 1 is located at Gurgaon, 10 kilometers from New Delhi International Airport

Factory 2 is located at Baddi, 300 kilometers from New Delhi International Airport and 40 kilometers from Chandigarh Airport

Tool Room

A key strength at Harsoria is our state-of-the art captive tool room with best-in-class CNC Machines including CNC Milling, CNC EDM and CNC Wire Cut. Operated up by a dedicated team of designers and engineers, Harsoria is able to design and manufacture most of our multi-cavity moulds in-house, in addition to Special Purpose Machines and fixtures required for assembly of medical devices. This in-house capability ensures that we are able to rapidly develop, validate and launch new models in a compressed time-frame. Additionally, having our in-house tooling equipment enables us to ensure a high degree of precision in the components with fine tolerance levels on the micron level.

Injection Moulding (Manufacturing of Components)

Our Injection Moulding Section houses All-Electric Horizontal Moulding Machines, Vertical or Hub Moulding Machines and Extrusion Lines in a Class 10,000/ISO Class 7 Clean Room. The majority of plastic components are moulded in-house at Harsoria on 100-ton and 180-ton Horizontal Moulding Machines. Additionally, for certain insert-moulded components, Vertical Moulding equipment are used to mate metallic parts with plastic ones. Harsoria also has in-house extrusion capabilities for rigid plastic tubes as well as soft Phthalate-Free PVC tubing. Our team of dedicated Quality Control professionals conducts in-process testing on all moulded and extruded parts for every shift. Moulded Components and tubing are stored prior to issue in our Component Store, also a Class 10,000 Clean Room.

Device Assembly

Harsoria Healthcare employs Automated Assembly Lines for production of devices such as the IV Catheters and Three Way Stop Cocks. These robotic assembly machines ensure a highly efficient and reliable assembly process for our manufactured medical devices. Equipped with in-line sensors, cameras and testing equipment, automated assembly ensures a high degree of batch-to-batch consistency. Other devices are assembled in a semi-automated process with table-top fixtures operated by trained man-power. All devices are visually inspected after completion of the assembly process to ensure conformity with product requirements.

Primary Packaging/Blister Packing

Fully-assembled devices are moved into the Blister Packing section for packaging into rigid or soft unit packs. These Unit Packs are given specific shapes based on the device design with forming and sealing dies loaded onto automated blister packaging equipment. Harsoria uses only Medical-Grade Paper as the Top-Web and Validated Rigid or Soft Films for the Bottom Web to ensure compliance with ISO 11607 international standard for packaging. Importantly, Harsoria employs online printing technology for real-time inscription of Batch Numbers, Expiry Dates and Unique Device Identifiers (UDI) on all unit packs.

Final Inspection & Packing (Cartoning Area)

Once the product is secured inside a blister pack, it is moved into the Cartoning Area or Final Inspection and Pacing Section. Here, dedicated personnel conduct 100% inspection of each and every Unit Pack for printing defects and other quality issues. Only after this rigorous inspection is the product packed into Inner Boxes and Master Cases.

Material Receipt Storage & Issue

The journey of every medical device begins with the procurement of high-quality, pre-qualified and standardized raw materials. At Harsoria Healthcare, we ensure that only validated raw materials are used in our medical devices. Upon receipt, all batches of raw materials are subjected to rigorous quality inspections at the incoming stage, including physical and chemical testing. Until such time that the QC releases these materials after completion of required tests, they are retained in the ‘Under Test’ section of our Raw Material Store. Primary and Secondary Packaging Material, Plastic Granules, Components and Chemicals are stored in separately demarcated areas of the Store. Traceability of raw materials used in all production lots is ensured by a team of trained personnel tasked with issuing these to shop floors.

Ethylene Oxide Gas Sterilization

At Harsoria, we employ Terminal Ethylene Oxide Sterilization for all sterile devices. This process requires the finally packed master cases to be placed inside a Stainless Steel Chamber where it is exposed to ethylene oxide gas and steam under controlled conditions. The Sterilization Cycle for all devices is validated as per the ISO-11135 Standard to conform with international requirements. Trained Operators monitor and ensure strict control of parameters of the sterilization process, namely Temperature, Humidity, EO Concentration and Time of Exposure. After sterilization, the finished product is moved into the Quarantine area of the Finished Goods Store. Here product is stored until testing is completed and Release Order is issued by responsible persons in the QC/QA functions.

Testing Facilities at Harsoria

  • Triple-Testing, i.e. testing at the Incoming, In-Process and Finished Goods Stages.
  • Visual, dimensional, functional and microbiological tests to ensure compliance with product standards such as ISO 10555-1 for IV Catheters, ISO 80369-7 for Luers and Stop Cocks and US Pharmacopoeia for Sterility.
  • In-House fully equipped Physical/Functional Testing Laboratory with apparatus for Tensile Testing, Pressure Leakage Testing, Flow Rate Testing, Penetration Testing, etc.
  • Micro-biological Testing Laboratory for Product Bio-Burden, Clean Room Monitoring as well as 14-day Sterility Testing