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Manufacturing
Scalable & Compliant
U.S. based cGMP manufacturing designed for speed, flexibility, and precision.
The GMP Facility
Our modular cleanroom environments are designed for regulatory compliance and process scalability:
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Facility Specs: A 6,000 sq ft facility featuring ISO Class 7 and ISO 8 suites with flush finishes.
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Contamination Control: Dedicated and segregated HVAC systems utilize pressure differentials and HEPA air handlers to manage product and personnel flow.
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Environmental Monitoring: Continuous particle and VOC (Volatile Organic Compound) counting ensures environment integrity.
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Safety Infrastructure: Includes 18 feet of chemical fume hood space and hazardous vapor ventilation control to accommodate class 6.1 Hazmats.
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Integrated Synthetic Equipment
Our suites support end-to-end chemical and pharmaceutical workflows with a robust inventory of in-house equipment:
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Reactors: Batch chemical reactors ranging from 100 mL to 600 L, operational from -40°C to +300°C.
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Separation & Filtration: Multi-stage distillation columns, pharmaceutical basket centrifuges, and non-metallic filter presses for up to 20 kg solid batch capacity.
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Vertical Integration: On-site high-purity gas generation (O2, N2, H2) and USP-grade RO water systems for formulation and cleaning.
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Advanced Controls: A computerized laboratory provides automated and remote control of reaction stages for continuous monitoring and early detection of discrepancies.
Our 5 Step Development Process
We utilize a structured workflow to move your material concept from discovery to clinical supply:
1
Assess
Gap review, establishment of a target product profile (TPP), and risk mapping.
2
Design
Determination of route or formulation strategy and definition of acceptance criteria.
3
Prove
Method verification, prototype development, and ICH stability testing.
4
Transfer
Preparation of GMP documentation, master batch records, and validation plans.
5
Supply
Production of clinical lots, ongoing Quality Control (QC), and change control management.
Why Partner with Parimer?
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