Custom Injection Pen Manufacturing Process

A Complete Guide to Standard OEM & ODM Workflow

Injection pens are widely used for GLP-1 medications, peptides, insulin, and specialty biologics. As demand for brand-differentiated medical devices increases, more pharmaceutical companies and healthcare brands are turning to customized injection pens to enhance product performance, user experience, and market competitiveness.

This article explains the standard customization process, from concept to mass production, giving customers a clear view of how we design and manufacture professional-grade injection pens.

**1. Step 1 — Requirement Collection

Understanding Your Drug, Dosage & Application**

Every customization project starts from a deep understanding of the customer’s needs:

✔ Medication characteristics

• Viscosity

• Volume (1 mL / 2.25 mL / 3 mL / 4 mL etc.)

• Injection force requirements

• Stability & compatibility

✔ Dosage structure

• Fixed dose / variable dose

• Units, mg, IU, clicks

• Minimum & maximum dose per injection

✔ Usage scenario

• Self-injection / clinical-use

• Frequency (daily, weekly, monthly)

✔ Branding & appearance needs

• Color

• Material (PC, ABS, aluminum, stainless steel)

• Logo printing / laser engraving

• Packaging design

This step ensures we configure the right pen platform for your medication.

**2. Step 2 — Technical Feasibility Evaluation

Engineering Review & Pen Model Selection**

Our engineering team evaluates:

✔ Mechanical structure compatibility

• Whether the pen can deliver required dosage strength

• Whether the plunger rod matches your syringe type

• Whether 1 mL or 2.25 mL PFS fits the design

✔ Regulatory feasibility

• ISO 11608 compliance

• ISO 13485 manufacturing system

• CE / FDA technical documentation readiness

✔ Customization complexity

• Custom dosage knobs

• Custom clutch structure

• Custom housing or grip design

• Special materials or surface treatment

A detailed proposal is then provided to the customer for confirmation.

**3. Step 3 — 3D Design, Rendering & Sampling

Product Visualization Before Tooling**

Our R&D team develops:

✔ 3D CAD design

For housing, dosage window, knob, clutch, inner mechanism.

✔ Appearance rendering

To show real visual effect of colors, finishes, and textures.

✔ Prototype samples (3D printed or CNC)

For design validation, ergonomic testing, and hand-feel confirmation.

At this stage, customers can request design changes before molding begins.

**4. Step 4 — Mold Making & Component Manufacturing

Precision Injection Molding for Medical Devices**

Once the design is approved, we begin tooling.

✔ Mold fabrication

• High-precision steel molds

• Multi-cavity design for high output

• Strict tolerance control for medical injection pens

✔ Component manufacturing

Using high-quality medical-grade materials:

• PC / ABS / POM / PP

• Aluminum alloy

• Stainless steel

Every batch undergoes dimensional and functional inspection.

5. Step 5 — Surface Finishing & Custom Branding

Depending on customer needs, we provide:

✔ Laser engraving (scale, logo, serial number)

✔ Silk-screen printing (brand name, instructions)

✔ Anodizing (for aluminum pens)

✔ UV coating & matte finish

✔ Custom color injection molding

Each pen becomes a brand-unique medical device that stands out in the market.

**6. Step 6 — Assembly & Quality Testing

Strict Medical-Grade QC Procedures**

Our assembly line follows ISO 13485 medical device manufacturing standards.

✔ Key testing procedures include:

• Injection force testing

• Torque & rotational accuracy

• Dose accuracy and repeatability

• Needle connection and compatibility check

• Clutch engagement stability

• Mechanical durability test (life cycle test)

✔ Sterilization-ready process (if required)

Pens can be supplied:

• Fully assembled

• Semi-assembled

• With PFS installed (for pharmaceutical partnerships)

7. Step 7 — Packaging, Labeling & Regulatory Documents

We offer customizable packaging options:

✔ Blister packs

✔ Medical-grade paper–plastic packaging
✔ Customized gift boxes
✔ White-label or OEM packaging

Documentation support includes:

• CE technical files

• ISO certificates

• Material data sheets

• Compatibility test reports

• Product specification files

(Available depending on customer project & compliance requirements.)

8. Step 8 — Mass Production & Global Delivery

Once everything is approved:

• We proceed to mass production

• Perform batch QC inspections

• Prepare export documents

• Arrange global shipping (air/sea/express/DDP)

Our production capacity supports small-batch trial orders to large-scale pharmaceutical cooperation.

Conclusion: A Smooth & Transparent OEM/ODM Process

From design to delivery, every step of our injection pen customization process is engineered for precision, safety, and brand differentiation.

Why customers choose our customization service:

• 10+ years of injection pen expertise

• Top-level engineering team

• ISO 13485 certified factory

• Strong OEM/ODM capability

• Fast sampling & stable mass production

• Full branding customization options

Whether you’re launching a new GLP-1 product, peptide therapy, or specialty medication, we help you create a professional, market-ready injection pen solution.