IPQC Isolators

Our IPQC isolators deliver world-class containment and regulatory-compliant solutions for in-process quality control (IPQC) sampling, testing, and weighing in pharmaceutical, biotech, and API production facilities. Designed to meet GMP, cGMP, and ISO 14644 standards, these isolators safeguard operators, protect product integrity, and maintain cleanroom classifications — ensuring consistent, contamination-free results every time.

Design Features

GMP-compliant stainless-steel construction for superior hygiene and cleanability
ISO 5 / Grade A laminar airflow with validated HEPA or ULPA filtration
Operator-friendly glove ports designed for ergonomic comfort and precision handling
Rapid Transfer Ports (RTPs) and safe pass-through systems for seamless, sterile material transfer
Integrated pressure monitoring and leak detection for uncompromised containment
Clear viewing panels for maximum process visibility and safe supervision

Technical Specification

Containment performance: <1 µg/m³ OEL (Occupational Exposure Limit) for potent APIs
Airflow configuration: Laminar or turbulent flow depending on process requirements
Filter class: H14 HEPA or U15 ULPA with in-situ integrity testing capability
Pressure regime: Positive or negative pressure with digital display and alarms
Material of construction: SS 316L with polished finish (Ra ≤ 0.6 µm)
Compliance: Fully aligned with EU GMP Annex 1, FDA guidance, and cGMP

Operational Benefit

Protects operators from potent compounds and hazardous materials
Maintains sterility to prevent cross-contamination and ensure batch integrity
Reduces downtime with quick-change filters and easy cleaning protocols
Supports regulatory audits with electronic records and validation documentation
Improves efficiency in IPQC workflows, from sampling to data collection

Applications

Pharmaceutical IPQC sampling and in-process testing
Biopharma cell culture and media handling in a sterile environment
Potent API containment for oncology and high-potency drug manufacturing
Aseptic weighing, dispensing, and sample preparation
R&D and pilot-scale production requiring controlled environments

Supply Options

Custom-engineered isolators tailored to your specific process needs
Modular or skid-mounted configurations for flexible facility layouts
Turnkey solutions including FAT, SAT, IQ/OQ/PQ documentation
Global service and maintenance support with rapid spare parts availability

IPQC Isolators

IPQC Isolators

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Design Features

Technical Specification

Operational Benefit

Applications

Supply Options

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