ISO 13485:2016 • CE 0197 • CLASS 100K CLEANROOMS • TURNKEY PRIVATE LABEL

OEM, ODM & Contract Medical Device Manufacturing

Goel Allied Industries (AI-DISPO®) is a premier global manufacturing partner for multinational healthcare corporations, pharmaceutical brands, and government health institutions. We deliver high-precision multi-cavity injection molding, automated cleanroom assembly, custom private-label printing, and certified in-house ETO gas sterilization.

CONFIGURE OEM PROJECT → EXPLORE CAPABILITIES

END-TO-END MANUFACTURING EXCELLENCE

Our Contract Manufacturing Capabilities

From custom mold design and micro-precision polymer injection to sterile barrier blister packaging and global regulatory submission dossiers.

Tooling & Multi-Cavity Injection Molding

State-of-the-art all-electric robotic injection molding lines handling up to 128-cavity hot-runner precision molds with ±0.01 mm dimensional tolerance. Medical virgin PP, HDPE, and polycarbonate.

High-speed robotic parts extraction
Hot-runner balanced melt distribution
Optical camera in-mold QC verification

Private Labeling & Custom Scale Printing

Complete brand customization including client logo pad printing, custom volumetric increment markings in specialized inks, color-coded plunger rods, and bespoke multi-lingual packaging artwork.

High-contrast indelible medical inks
Custom colored plunger & hub options
GS1 DataMatrix & UDI barcode printing

Automated Cleanroom Assembly (Class 100k)

Robotic assembly suites operating under validated ISO Class 8 / Class 100,000 cleanroom conditions with HEPA filtration, automated cannula insertion, silicone micro-spray, and automated hub bonding.

Dow Corning ultrasonic silicone coating
Automated needle tip geometry check
Zero human contact during assembly

Flexible Packaging Formats

High-speed thermoforming blister lines utilizing medical-grade peel-open coated paper or Tyvek®, ribbon packs, non-sterile bulk component shipping, and customized inner cartons.

Medical paper & Tyvek® blister packs
Ribbon pack & polybag options
Heavy-duty 5-ply export shipper cartons

In-House ETO Sterilization & Aeration

Industrial computerized Ethylene Oxide sterilization chambers programmed for deep vacuum, controlled humidity conditioning, gas penetration, and rapid residual desorption with biological spore confirmation.

Guaranteed SAL 10⁻⁶ sterility level
ISO 11135 validation protocols
In-house residual EO & ECH gas analysis

Global Regulatory & Dossier Support

Full technical file support for national and international regulatory filings including European CE MDR (2017/745), US FDA 510(k), CDSCO (India), and national MOH registrations across Asia, Africa & Latin America.

ISO 10993 Biocompatibility test reports
Accelerated & real-time stability studies
Complete Plant Master File (PMF) support

SEAMLESS ONBOARDING ROADMAP

Our Turnkey 6-Step OEM Process

From initial technical consultation to global export container delivery, we handle every phase with clinical precision.

Engineering & Spec Alignment

NDA signing, 3D CAD modeling, raw material grade selection, and regulatory classification review.

Tooling & Prototype Sampling

Mold manufacturing, pilot prototype runs, hydraulic seal verification, and client sample approval.

Cleanroom Pilot & Sterility Validation

Pilot cleanroom production, bioburden testing, and ISO 11135 ETO sterilization cycle validation.

Technical Dossier & QA Sign-Off

Compilation of Certificate of Analysis (COA), biocompatibility data, and customer QA formal sign-off.

Full-Scale Mass Production

24/7 automated cleanroom manufacturing with 100% in-line optical vision inspection.

Global Export & Logistics Delivery

Palletized container loading, customs documentation, and CIF/FOB delivery to your destination port.

CUSTOMIZE YOUR SPECIFICATIONS

Interactive OEM Project Configurator

Select your device architecture, packaging standard, and volume parameters to generate a customized OEM specification summary.

1. Select Target Medical Device:

2. Branding & Labeling Mode:

3. Sterile Packaging Format:

4. Estimated Annual Volume:

GENERATED OEM SPECIFICATION

Project Summary Preview

Product Scope: Disposable Syringes (1mL – 50mL)

Branding Level: Full Private Label

Packaging: Individual Medical Paper Blister

Target Volume: 100k – 500k Units

Sterility Assurance: ETO Sterilized (SAL 10⁻⁶)

Audit Standard: ISO 13485 / CE / WHO-GMP

🔒 Strict NDA Protection & Technical Feasibility Consultation

QUALITY & REGULATORY COMPLIANCE

Accredited Quality Standards

REGULATORY STANDARD	ACCREDITATION BODY	APPLICABLE OEM SCOPE	BENEFIT FOR PRIVATE LABEL CLIENTS
ISO 13485:2016	International Notified Body	Medical Devices Quality Management System	Fast-track market authorization and recognized quality worldwide.
European CE 0197 Mark	TÜV / European Notified Body	EU Medical Device Regulation (MDR 2017/745)	Direct sales authorization across EU and EEA member states.
WHO-GMP Compliance	World Health Organization Standards	Cleanroom Facilities & Sterile Manufacturing	Eligibility for international tenders, UNICEF, and global health NGOs.
CDSCO License	Ministry of Health, Govt. of India	Medical Device Manufacturing & Testing	Full national regulatory clearance and institutional hospital supply.
ISO 11135 / ISO 10993	Accredited Testing Labs	ETO Gas Sterilization & Biocompatibility	Complete cytotoxicity, irritation, sensitization, and pyrogen dossiers.