Cleanroom Thermoforming Packaging Manufacturer IndiaISO Class 8, GMP Validated, Vapi
A validated Cleanroom Class 8 production environment for pharmaceutical GMP blister packaging and medical device blister component manufacturing — with complete session-level documentation per production run.
Our Cleanroom Class 8 Facility
Trizen Packaging is a cleanroom thermoforming packaging manufacturer in India operating a validated Cleanroom Class 8 facility at our Vapi, Daman production site. The cleanroom is used for pharmaceutical GMP blister packaging production and medical device blister component manufacturing — the two thermoforming packaging applications that require a particulate-controlled production environment.
Cleanroom Class 8 (ISO 14644-1) is a HEPA-filtered, controlled-airflow production environment maintained below a defined maximum airborne particulate concentration. Combined with our GMP validation and ISO 9001:2015 certification, it forms the complete quality infrastructure for regulated thermoforming packaging manufacturing at Vapi.
Pharmaceutical and Medical Device Packaging from the Cleanroom
| Application | Our Manufacturing Scope | Documentation Provided |
|---|---|---|
| Pharmaceutical GMP Blister PackagingPVC · PVDC · Alu-Alu Cold Form | Thermoformed pharmaceutical blister cavity sealed with pharmaceutical aluminium foil — produced under GMP in our Cleanroom Class 8 facility. Complete blister packaging component supplied to the pharmaceutical manufacturer for use on their filling line. | GMP batch records · Material COAs · In-process QC · Outgoing inspection · Cleanroom session records per batch |
| Medical Device Blister ComponentsPETG / APET + Tyvek · ETO & Gamma compatible | Thermoformed PETG or APET blister tray and Tyvek-sealed blister component in ETO and Gamma compatible materials. Manufactured in Cleanroom Class 8. Supplied empty — device loading and sterilization are performed by the device manufacturer in their own facility. | GMP batch records · Material COAs · Cleanroom session records · In-process QC per batch · 5-year retention |
Cleanroom Packaging Manufacturer Vapi DamanWhy Choose Trizen?
As a cleanroom packaging manufacturer from Vapi Daman, our facility holds three certifications covering the full scope of pharmaceutical and medical device packaging manufacture from one site:
Frequently Asked QuestionsTrizen expertise and services
Trizen Packaging is a cleanroom thermoforming packaging manufacturer in India operating a validated Cleanroom Class 8 (ISO 14644-1) facility at Vapi. Used for pharmaceutical GMP blister packaging and medical device blister component manufacturing. Three certifications at Vapi: ISO 9001:2015, GMP, and Cleanroom Class 8.
GMP batch records, material COAs from the material manufacturer, Cleanroom session records (environmental monitoring, HEPA filter status, operator records), and in-process QC data — per production batch. Retained 5 years post-production for supplier qualification audit access.
Request Our Qualification Package
ISO 9001:2015 certificate, GMP certificate, and Cleanroom Class 8 documentation — available for supplier qualification review before order placement.