Pass Your GMP/PIC/S Audits with Confidence

Worried New Equipment Won't Pass GMP/PIC/S Audits?

In Pharma and Biotech, the biggest fear isn't machine breakdown—it's facing an inspector without the right documentation. Are you concerned about:

Material Compliance Risks: Being challenged by auditors because liquid-contact parts lack material certificates (Mill Sheets)?

Cleaning Validation (CV) Failures: Dead legs (dead angles) in piping design causing residue buildup, making Cleaning Validation impossible to pass?

Documentation Gaps: The manufacturer failed to provide IQ/OQ/PQ protocols, causing severe delays in your validation timeline?

Hozun's Promise: "Audit-Ready" Compliant Equipment

We understand regulatory pain points. We integrate cGMP methodology from the very first design phase:

1. Material Traceability

All liquid contact surfaces use SUS316L Medical Grade Stainless Steel or FDA-compliant materials. We provide full Material Certificates and Surface Roughness (Ra) reports upon delivery.

2. Hygienic Design (Dead-Leg Free)

Piping utilizes Sanitary Tri-Clamps and pump chambers are designed without dead angles to ensure effective CIP/SIP sterilization, drastically reducing cross-contamination risks.

3. Full Validation Support (IQ/OQ)

We help you cross the finish line. Hozun provides standard IQ/OQ Protocol Templates and test plans to accelerate your validation process and get your line running sooner.

Choosing a Compliant Supplier is Cheaper Than Fixing Audit Findings Later!

Check if your target model meets regulatory standards today.

Get Compliant Quote Email Us