Mediplus (India) Limited

Mediplus (India) Limited
www.mediplusindialtd.com
A Brief Presentation
by
Mediplus India Ltd
Corporate video
• MEDIPLUS India Ltd incorporated IN 1995, promoted by Goel

family and 100% family owned
• Factory is located at Bahadurgarh, 35 Km. from Delhi International
Airport
• The factory has a covered area of 40,000 Sq. Ft., with about
11,700 Sq. Ft. as Cleanrooms
• Core team consists of experienced technical and commercial
professionals
Manufacturing License & Certifications

• Drugs Manufacturing License from CDSCO, Government of India
• GMP Certificate from CDSCO, Government of India
• ISO 9001:2015 & ISO 13485:2016 certification through independent
audits by SGS Certification Services Limited UK
• Products CE Marked through independent audits by SGS Certification
Services Limited UK
• Currently in process of 510 K registration (US FDA) for its range of
Safety Intravascular Catheters
Mediplus India Ltd Today

• Sales Turnover: USD 10 Million
• Number of Employees: 480
• Export Market Presence: 48 Countries
• IV Catheters Capacity: 146 Million Pieces/Annum
• Three Way Stop Cocks capacity:30 Million Pieces/Annum
Production Order
Product Flow Chart
Injection machine Set up Plastics Injection
Components Process
Injection & Stamping
Area Stamping Machine Set up
Stamping
Material Requisition Metal Clip
Material Requisition Intravascular Process
Catheter &
machines Set up Stop Cock
Clean Room Segregation
In-process
Intravascular and
control
Catheter No Disposition
Auto-Assembly Process
Yes
Material Requisition
Segregation
Intermediate
No and
Buffer Stage
In-process Disposition
Intravascular Catheter
No
control
Manual Assembly
Product
Yes Sterilization Process Deaeration Room
No Pre-Conditioning
Blister Packaging In-process Conforms ?
control No
No Yes Product
Yes Quarantine Area Sterile
In-process
Blister Packaging
control
Buffer Stage
Quality Control No
Yes Pyrogen
Result
Product Packaging
Final Inspection
Packaging Area
Delivery of finished
product to warehouses
Quality Policy
We at MEDIPLUS India Ltd are committed to be:
Customer Focused
Satisfy our customers’ needs and expectations;
Make commitments we fully understand and believe we can meet;
Meet all commitments to customers on time, while meeting applicable Regulatory & Legal Requirements
Performance Driven
Verify that our products and services meet agreed requirements;
Monitor, benchmark and continuously improve our business, products
and services, organization and employees’ performance.
Risk Control
To identify all hazards associated with products, estimate and evaluate the associated risk and controlling these risks
so that the risk could be eliminated.
Achieving MEDIPLUS’s Mission and Goals

Sustain and develop business growth and Intellectual Property
Manufacturing (Cleanrooms) Areas

(11700 Sq. Ft.)
• 2,500 Sq. Ft. Class 100,000 Cleanroom for Injection Molding 1

• 1,500 Sq. Ft. Class 100,000 Cleanroom for Injection Molding 2
• 3,000 Sq. Ft. Class 10,000 Cleanroom for Automatic Assembly 1
• 2,500 Sq. Ft. Class 10,000 Cleanroom for Automatic Assembly 2
• 2,200 Sq. Ft. Class 10,000 Cleanroom for Automatic Assembly 3 & Blister
Packing (Rigid & Soft Blisters)
Manufacturing Processes & Capacities

• High Speed Injection Moulding: 1,200 Million Components Per Annum
• High Speed Stamping: 50 Million Safety Clips Per Annum
• Automatic Assembly of I.V. Catheters: 130 Million Per Annum
• Semi-Automatic Assembly of I.V. Catheters: 16 Million Per Annum
• Automatic Assembly of Three Way Stop Cocks: 30 Million Per Annum
• Blister Packaging of Devices: 200 Million Per Annum
• Sterilization of Devices: 200 Million Per Annum
• Complete Injection moulding (Class 100,000 Cleanrooms as per ISO 14644) done
on All Electric Injection Moulding Machines sourced from Toshiba Japan and
Fanuc Japan
• Class 100,000 Cleanrooms and Fanuc Japan

High Speed Stamping Machine

• High Speed Stamping Machine (150 Strokes Per Minute): 1 No.
Automatic Assembly
• Automatic Assembly Machines (Conventional IV Catheters with Injection Valve): 12 Nos. (4 of
these Machines comprise One Complete Line)
• Automatic Final Assembly Machine for Two Way IVC: 1 No.
• Automatic Assembly Machine (One Way IV Catheter Body): 1 No.
• Automatic Final Assembly Machine for One Way IVC: 1 No.
• Automatic Tip Forming and Inspection Machines: 3 Nos.
• Automatic Assembly Machine (Slider Safety System): 1 No.
• Automatic Assembly Machine (Tip Cover Safety System): 1 No.
• Automatic Assembly Machine for Three Way Stop Cock: 1 No.
• Automatic Filter Sealing Machine for Flash Back Chamber: 1 No.
• Automatic Assembly Machine for Injection Stopper: 1 No.
• Class 10,000 cleanrooms for Product Assembly and Blister or Pouch packing (as per ISO
14644)
Blister Packaging
• Five Blister Packaging machines for Rigid Blister Packing of
Intravascular Catheters & Three Way with online printers
Capacity: 130 million pieces per annum
• Two Blister Packaging machines for Soft Blister Packing of
Intravascular Catheters & Three Way with online printer
Capacity: 70 million pieces per annum
• One Blister Packaging Machine for Miscellaneous Products with
online printer
• Soft Blister Packaging Machine with online printer

• Rigid Blister Packing Machines with online printer

• Checking & Packing after Blister Packing

Sterilization Process
• One Automatic Pre-conditioning Chamber: 15 Cubic Meter
• One Automatic EO Sterilizer: 15 Cubic Meter
• Sterilization Capacity: 170 million IVC/Annum & 30 million Three
Way Stop Cock/Annum

Sterilization Machine Automatic Controller

Pre-conditioning Chamber
(15 Cubic Meter)
Sterilization Chamber
(15 Cubic Meter)
Pre-humidification Chamber & Sterilization Chamber

Automatic Ethylene Oxide Gas Scrubber

Finished Goods Store

Product & Process Quality

The complete Incoming, In-process and Finished Product Quality Controls are
ensured in an in-house Environmentally Controlled Quality Assurance Lab
(approved by CDSCO) comprising:
• Biological Testing,
• Microbiological Testing and
• Physico-Chemical Testing
Sterility Testing
Pyrogen Testing (Bacterial Endotoxin Test)

Chemical Testing
Melab Catheter Penetration Testing

Finished Products
(Inspection guidelines and manufacturing standards)
• ISO 10555-1:2013 Intravascular catheters – Sterile and single-use catheters – Part 1:

General requirements
• ISO 10555-5:2013 Intravascular catheters – Sterile and single-use catheters – Part 5:
Over-needle peripheral catheters
• ISO 11070:2014 Sterile single-use intravascular catheter introducers
• ISO 14972:1998 Sterile Obturators for single-use with Over-needle peripheral
intravascular catheters
• ISO 7864:2016 Sterile hypodermic needles for single-use
Finished Products
(Inspection guidelines and manufacturing standards Continued)
• ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation

and testing with a risk management process
• ISO 11135:2014 Sterilization of health care products – Ethylene Oxide – Part 1:
Requirements for development, validation and routine control of a sterilization
process for medical devices
• ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1:
Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2:
Validation requirements for forming, sealing and assembly processes
Finished Products
• EN ISO 14971:2012 Medical devices – Application of risk management of medical

devices
• ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical
Use
• ISO 80369-7:2016: conical fitting with a 6 % taper for syringes, needle and other
medical equipment
• Indian, European and US pharmacopoeia
• ISO 2859 Sampling procedures and tables for inspection by attributes
Finished Products
• ISO 23908:2011 Sharps injury protection – Requirements and test methods –

Sharps protection features for single-use hypodermic needles, introducers for
catheters and needles used for blood sampling
• ISO 14644-1:2015 Cleanrooms and associated controlled environments
• ISO/TR 14969:2004 Medical devices – Quality management systems –
Guidance on the application of ISO 13485:2003
• ISO 10012:2003 Measurement management systems – Requirements for
measurement processes and measuring equipment
• ISO 19011:2011 Guidelines for quality and/or environmental management
systems auditing
Extensive In-house Design & Development

(Key to Mediplus India Ltd success)
Concept to Creation done in-house with latest CAD CAM solutions as follows:
• Product Design, prototyping and pilot lot manufacturing
• Injection Moulds Design, Development & Manufacturing
• Sheet Metal high Speed Stamping Dies Design, Development and manufacturing
• Assembly Jigs & Fixtures Design, Development and manufacturing
• Semi-automatic assembly systems Design, Development and Manufacturing
• Maintenance and servicing of the above and the Maintenance of bought out Fully
Automatic Assembly Machines
Complete product design done in-house, involving latest CAD-CAM solutions on Solid
Works 3D software
Mediplus India Ltd has succeeded in making complex and

High Speed Moulds & Press Tools
• Our Moulds are hot runner, multi-cavity, and some moulds produce more than 100
components in a single shot.
• Design of the Moulds is versatile, we produce different sizes and variations from the
same Mould.
Most Modern CNC Spark Erosion Machine from

Charmilles Switzerland
Most Modern Quality Control Equipments from NIKON, MITUTOYO,

TRIMOS, CARL ZEISS etc.
Design & Development-Infrastructure

• Special Purpose Machines
• CNC Spark Erosion (AGIE-Charmilles)
• NC Spark Erosion (AGIE-Charmilles)
• Conventional Tool Room Machines
• Milling Machines (Taiwan)
• Lathe Machines
• Surface Grinder (Okamoto Japan)
• Tool & Cutter Grinders
• Spark Erosion Machines
• Drilling Machines
Design & Development-Infrastructure

(Continued)
• 3D Modeling/Design Softwares
• Solid Works Professional
• AutoCAD
• Quality Control
• Microscope (Nikon Japan)
• Measuroscope (Mitutoyo Japan)
• Height Master (Trimos Switzerland)
• Surface Roughness Tester (Mitutoyo Japan)
• Other Measuring Devices (Carl Zeiss, Mitutoyo, Tesa etc.)
WE STRICTLY FOLLOW ETHICAL PRACTICES

• Full compliance to all labour laws
• No under-age workers
• All workers are paid above the state’s minimum wage
• All workers covered under Employees State Insurance Scheme
• Company contributes to Provident Fund (Social Security) for all workers and
employees
• Proper safety measures are adopted

• Cleanliness and hygiene are paramount in all departments
• Adequate provision for fire-fighting and other safeguards (like easy emergency
exits) in case of unforeseen eventualities
• Non-polluting manufacturing facilities
• Effective rain water harvesting in place
MEDIPLUSDISPOSABLES
Mediplus India Ltd range of products include:
• Range of Safety Intravascular Catheters
• Range of Intravascular Catheters
• Three Way Stop Cock
• Three Way Stop Cock with Extension Tube
• Injection Stopper
• Other Accessories
Plusclip Safe
(Safety Intravascular Catheter with Port and Wings)
Pluscan Alpha Safe – S

(Safety Intravascular Catheter without Port & Wings)
Marketing & Sales

Mediplus products are presently coveted by discerning buyers in more than 48 countries globally
Future Plans
• Automation Activities:
• To accelerate Automation activities such that the entire production of all types of IV Catheters
is fully automated
• Introduce automatic product placement in the formed Blister on the Blister Packing Machines
• Introduce automation in visual inspection of individual blister/pouch packed products prior to
carton packaging
• New products under consideration:
• Core impetus on new Safety Devices like Safety Syringes and Safety Needles
• Seeking ideas from our esteemed customers regarding Sharp Safety Devices
• OEM Manufacturing:
• Currently exploring potential for oncology products
• Endeavour to seek opportunities for contract manufacturing of Infusion Devices
Mediplus (India) Limited

402-404, 4th Floor
R.G. Trade Tower
Netaji Subhash Place
Pitampura, New Delhi - 110034 (India)
Tel: +91 11 27353189, 47047481

Fax: +91 11 47082818
Email: info@mediplusindialtd.com
Web: www.mediplusindialtd.com
Thanks a lot for your attention

Mediplus (India) Limited

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Mediplus (India) Limited

• MEDIPLUS India Ltd incorporated IN 1995, promoted by Goel

Manufacturing License & Certifications

Mediplus India Ltd Today

Achieving MEDIPLUS’s Mission and Goals

Manufacturing (Cleanrooms) Areas

• 2,500 Sq. Ft. Class 100,000 Cleanroom for Injection Molding 1

Manufacturing Processes & Capacities

• Class 100,000 Cleanrooms and Fanuc Japan

High Speed Stamping Machine

• Soft Blister Packaging Machine with online printer

• Rigid Blister Packing Machines with online printer

• Checking & Packing after Blister Packing

• One Automatic Pre-conditioning Chamber: 15 Cubic Meter

• One Automatic EO Sterilizer: 15 Cubic Meter

• Sterilization Capacity: 170 million IVC/Annum & 30 million Three

Way Stop Cock/Annum

Sterilization Machine Automatic Controller

Pre-humidification Chamber & Sterilization Chamber

Automatic Ethylene Oxide Gas Scrubber

Finished Goods Store

Product & Process Quality

Pyrogen Testing (Bacterial Endotoxin Test)

Melab Catheter Penetration Testing

• ISO 10555-1:2013 Intravascular catheters – Sterile and single-use catheters – Part 1:

• ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation

• EN ISO 14971:2012 Medical devices – Application of risk management of medical

• ISO 23908:2011 Sharps injury protection – Requirements and test methods –

Extensive In-house Design & Development

Mediplus India Ltd has succeeded in making complex and

Most Modern CNC Spark Erosion Machine from

Most Modern Quality Control Equipments from NIKON, MITUTOYO,

Design & Development-Infrastructure

Design & Development-Infrastructure

WE STRICTLY FOLLOW ETHICAL PRACTICES

• Proper safety measures are adopted

• Range of Intravascular Catheters

• Three Way Stop Cock

• Three Way Stop Cock with Extension Tube

Pluscan Alpha Safe – S

Marketing & Sales

Mediplus (India) Limited

Tel: +91 11 27353189, 47047481

Thanks a lot for your attention

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