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Medical Device

Sterile Assembly Facility

ISO Class 8 modular cleanroom suite for medical device manufacturing compliance.

ISO Class 8
Classification
940 m²
Floor Area
16 weeks
Delivery
2024
Completed
The Brief

Sterile Assembly Facility — Johor Bahru, Johor

The facility packages single-use surgical components and had to satisfy ISO 13485 audit requirements without a long shutdown. CityPoint pre-fabricated the complete modular suite off-site — assembly hall, packing room, quarantine store and personnel airlocks — then installed and commissioned it in a single sixteen-week programme.

Every junction is coved and the envelope is finished in a non-shedding, chemically resistant skin that stands up to daily sanitisation. Material flow was designed one-way, with pass boxes separating the clean and dirty sides of every process step.

Fully modular suite pre-fabricated off site
One-way material flow with interlocked pass boxes
Coved, non-shedding surfaces rated for daily sanitisation
Documentation package aligned to ISO 13485 audit
Get in Touch

Let's build your perfect cleanroom

Planning a new facility, upgrading an existing cleanroom, or sourcing components — our specialists will guide you through every step.

TEL
Phone / WhatsApp
+6012 223 0200
@
Email
enquiry@citypoint.my
Head Office

City Point Solutions Sdn Bhd
No. 7, Jalan PP16/4, Perdana Industrial Park,
Taman Putra Perdana, 47130 Puchong, Selangor.

Monday – Friday, 8.30am – 5.30pm

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