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Aseptic Ophthalmic Complete Filling System

The Aseptic Ophthalmic Complete Filling Solution from Unscrambling, Filling, Weighing, Capping & Plugging up to production speed 200upm with Industrial 4.0 features.

PREMIUM FEATURES, AFFORDABLE PRICE

The Aseptic Ophthalmic Complete Filling Solution

Introducing “OphthaFill” – the complete aseptic ophthalmic filling solution from unscrambling, filling, weighing, Plugging and Capping, with a production speed up to 200 units per minute and Industrial 4.0 features. 

This solution is suitable for running both 3-piece and 2-piece preservative-free containers in an aseptic Class A Laminar or RABS environment, with real-time OEE visualization and 100% weight IPC. 

With a full servo-driven aseptic filling system for ophthalmic use, it is designed to adapt to a variety of packaging materials, and enables quick changeover ability.

  • Performance

    Walking beam Nozzle for one time filling to achieve more filling time for gentle filling, Individual Servo Filling pump for highest accuracy.

  • Product Safety

    Multiple detection and inspection available, 100% tare in tare out, under torque etc.

  • Conversion

    Full Servo Driven with rapid changeover via recipe and minimum change part.

  • Compliance

    15” IPC HMI comply to FDA 21 CFR Part 11 and European safety CE Marked

  • Digitalization

    Ready with OPCUA communication port for MES and ERP , Cloud base real-time OEE Monitoring

  • Barrier System

    LAF , Open RABs or Isolator design to GMP Annex 1.

  • Documentation

    Full Validation document DQ (RA, FSDS, HDS, SDS, CSV) , IQ, OQ

OVERVIEW

YOUR COMPLETE FILLING SOLUTION

HOW IT WORKS

The Aseptic Ophthalmic Filling System

Barrier System

  • Grade A or ISO Class 5 environment

  • Suitable for Laminar Flow, Open RABs or Isolator.

  • VHP compatible

Bottle Unscrambler

  • Empty containers are orientated by a Vibratory Sorter made of SUS316L.

  • It is designed without air jets used, to eliminate the risk of contamination.

  • Easy dismantle for Autoclave.

Bottle Handling

  • cGMP design

  • Gentle bottle handling via synchronize speed of pitcher to the main bottle indexer

Filling System

  • Ceramic Valveless Rotary Piston pump with stainless steel housing to enhance the robustness.

  • Individual Servo Drive for each piston, easy for volume adjust and volume fine increment / decrement via HMI.

  • Filling Accuracy up to ±0.5%

Weight IPC

  • 100% weight IPC tare in and tare out without compromise on speed.

  • High speed Weighing cell from European premium brand.

N2 Flushing

  • Pre and post N2 flushing for oxygen sensitive product.

  • With 0.2um Filter and flow sensor detection.

Plugging

  • Plug Sorting via SUS316L full welding mirror finishing vibratory bowl with autoclavable.

  • 2 axis Pick and Place robot accurately place the plug onto bottle.

Pre-Capping

  • Cap Sorting via SUS316L full welding mirror finishing vibratory bowl with autoclavable.

  • Pre-Capping Spindle via 3 Axis Robot to improve the capping yield.

Final Capping

  • Done by Servo motor with electronic torque control for highest repeatability, no more mechanical torque limiter wear and tear.

  • Spindle Height adjustment never been easier via recipe, no mechanical and skill needed.

  • Come with real time torque monitoring and under torque detection.

Unloading

Good Vial will be unload to the downstream conveyor by starwheel. Reject conveyor to automatically collect the reject bottle with reject verification and reject full features.

  • Product Safety detection

    Empty Fill detection, Missing plug detection, Missing cap detection, Cap under torque detection, Under / Over weight detection, N2 low detection

DETAILS

 HFS60HFS120HFS180HFS250
Speed50bpm   100bpm150bpm200bpm
Dosing Range5ml – 30ml
Packaging material3 piece part or Aptar bottle
Filling Accuracy+/-1% or better

The Aseptic Ophthalmic Complete Filling Solution from Unscrambling, Filling, Weighing, Capping & Plugging up to production speed 200upm with Industrial 4.0 features.

SOFTWARE

Software and Digitalization

Our unwavering commitment to excellence extends to our software. We meticulously curate premium solutions, introducing cutting-edge features designed to maximize your efficiency and productivity. This guarantees unparalleled performance and enduring reliability in every application

  • 15” IPC intuitive design HMI

  • Comply to FDA 21 CFR Part 11

  • Electronic Batch Record

  • Non-editable Audit Trial

  • 3 level user management

  • Recipes

  • OPCUA , MQTT communication ready

  • Cloud base Real-time OEE monitoring (optional)

SOFTWARE

Electronic Batch Records (EBR)

An Electronic Batch Record (EBR), contains all the information and data associated with the manufacturing process of a specific batch of pharmaceutical product.

  • It improved data integrity, real-time access to information, enhanced traceability, and streamlined compliance with regulatory requirements.

  • Also facilitate data analysis and reporting, helping you to optimize manufacturing processes and maintain high standards of product quality and safety.

SOFTWARE

FDA 21 CFR Part 11 Compliance

With Machine IoT, the machine OEE Data are collected and visualized in real-time anytime, anywhere by any smartphone or PC.​

  • The collected data can be drilled down to the month, week, day or batch.

  • The data can be further automatic analyze via machine learning for predictive maintenance purpose with notification alert.

  • This will have more Efficient & SMART Equipment Management.

BRAND WE USE

International Premium Brand

Our unwavering dedication to quality is reflected in the meticulous selection of premium and branded components for every machine we construct. 

By exclusively incorporating top-tier materials, we ensure that our machines not only meet but exceed industry standards, allowing them to perform at peak efficiency.

WHO WE ARE

"To Make Premium Affordable"

MH started in 1998 and was founded by Mr Ooi Meng Huat as a customized automation system design provider at an MNC company in Penang, Malaysia.

In 2002, driven by the belief that quality shouldn’t be unaffordable, especially for generic drug manufacturers, our founders, Mr Ooi Meng Huat and Co-Founder Mr Jeff Chong Chin Guan, transitioned from engineers to entrepreneurs. We began designing and manufacturing the MH brand Standard Filling System for Pharmaceutical and Cosmetic Industries, a testament to our expertise and dedication.

With ISO 9001, ISO 14001, and CE-marked certifications, we are committed to designing and manufacturing Filling Systems that meet the cGMP, FDA21 CFR part 11, and GAMP 5 International Standards and requirements. This commitment ensures the highest quality and safety of our products.

Nearly two decades of passion in design and manufacturing filling systems, we have established ourselves as a trusted Pharmaceutical machinery supplier, having successfully provided our Filling Line to 80% of Malaysia’s Pharma Manufacturers. This significant market share is a testament to our reliability and quality.

Besides Malaysia, MH has built more than 100 references in Southeast Asia, South Asia, and MENA countries, including Indonesia, Thailand, Singapore, Vietnam, Bangladesh, Pakistan, Egypt, Algeria, and Lebanon. Some of them are among the TOP 10 of the respective countries.

With the joining of our second-generation successor, MH aims to bring its value further to the global marketplace. Our company believes in making high quality affordable, and this has become its official brand tagline: 

“To Make Premium Affordable.”

OUR CUSTOMER

Customer Reference

Our company has installed over 400 complete filing lines for 125+ customers in the Pharmaceutical and Cosmetic industries across Southeast Asia, South Asia, and MENA countries.

TESTIMONIALS

Hear What Our Clients Have to Say!

CONTACT US

Request For Quotation

FAQS

Frequently Asked Questions

What are the advantages of full servo driven?
  • Rapid conversion

    No more mechanical height adjustment, just by recipe selection.

  • Higher repeatability

    No more depending on operator skill to adjust. Anyone can do it right.

  • Less maintenance

    No more complex and compact mechanism at the bottom of the machine that requires periodic maintenance, like greasing.

No more, you can adjust the fill volume anytime when machine running.

Yes, all roduct contacts part, including bottle unscramble, Plug bowl, cap bowl and filling pump, nozzzle, hose are made of FDA approved material SUS316L, Ceramics, silicone whch can be autoclavable.

it come with “suck back “ feature where last drop of liquid at the nozzle tip can be adjust to suck back. Such back force can be fine tune via HMI depends on liquid behaviour.