The ITHOS system, designed as a comprehensive PN (Parenteral Nutrition), Chemotherapy, and CIVAS (Centralised Intravenous Additive Service) online ordering solution that is manageable at any stage of the process offers a secure and efficient platform for all customers to manage their requirements.
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First-stage pharmaceutical transfer sanitisation involves loading raw materials onto trolleys, treating them with ionized hydrogen peroxide (iHP) mist, applying a complementary chemical disinfectant, and passing them through an airlock into the preparation room.
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The preparation room handles workflow setup by printing customer orders as batch manufacturing records, prioritizing production queues, and decontaminating raw components before transfer into sterile cleanrooms.
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This is a specialized, highly controlled environment where medications are compounded into bespoke medicines in response to an order supplied by the hospital.
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In cleanroom environments, a Grade A classification (equivalent to ISO Class 5) requires the most stringent standards for airborne particles and microbial limits.
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The iHP unit is a cutting edge, cleanroom bio-decontamination system. It delivers a 6-log reduction of bacteria, viruses and mould on surfaces and in the air.
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Compounding release checks verify product identity, integrity, and safety through physical inspections and paperwork reconciliation before final dispatch.
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A luminometer evaluates enzyme indicators to enable real-time product clearance and release following ionised hydrogen peroxide disinfection.
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The EM2400 Compounder configuration undergoes independent quantitative verification using an iCap system for electrolyte analysis and a refractometer for glucose measurement.
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The packing and dispatch area serves as the final, critical checkpoint between sterile manufacturing cleanrooms and direct patient care across hospital networks. Because ITH Pharma specialises in high-risk, unlicensed compounded sterile products (CSPs) PN, Chemotherapy, and CIVAS,the packing and dispatch process acts as an active guarantor of medication efficacy, cold-chain safety, and life-saving clinical timing.
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Storage and warehousing at ITH are critical for maintaining the safety, quality, and regulatory compliance of specialized aseptic compounding.
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Personnel flow in a pharmaceutical cleanroom protocol follows a strict, sequential progression from uncontrolled zones to the critical core and back out through dedicated exit paths.
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Access route for preparation and release-room staff. Staff don overshoes, sterile scrubs, mob caps, beard snoods, and sanitise their hands on entry.
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This airlock acts as a buffer zone that stabilizes air pressure and prevents outside air mixing before active gowning.
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Cleanroom personnel don full, sterile or specialized cleanroom garments (hoods, suits, boots, and gloves) using step-over benches to separate dirty and clean sides.
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The sterile or controlled manufacturing environment where operators perform sensitive pharmaceutical tasks under strict airflow and behavioural limits.
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The dedicated de-gowning space where personnel remove and discard or separate used cleanroom garments upon leaving the core, preventing reverse contamination.
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Access route for preparation and release-room staff. Staff don overshoes, sterile coats, mob caps, beard snoods, and gloves, and sanitise their hands on entry.
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