A FULL VALIDATION WITH OUR EQUIPMENT
The standards of good manufacturing practice (cGMP) require special attention to risk assessment and verification procedures: “… it is requirement of good manufacturing identify the activities of validation necessary to demonstrate control critical aspects of particular operations.
The significant changes made to installations, equipment and processes, which may affect product quality, should be validated. A procedure for risk assessment should be used to determine the scope and extent of validation.” The Validation Master Plan serves to make sure that all equipment, procedures, that may affect the quality or integrity or effectiveness of the product, are validated; it contains the general principles which comply during the validation task, and plans activities to be carried out for this purpose. All the equipment brands proposed by American Pharma Technologies follow, step-by-step, the technical rules and the standard protocols required (e. g., DIN, ASME, GMP and FDA / ISPE Guidelines). This fact makes the Validation process natural and effective.
WATER TREATMENT, THE FIRST STAGE
American Pharma Technologies offers a wide range of pharmaceutical water treatment equipment and systems (e.g. pretreatment, reverse osmosis, vapor compression and multiple effect distillation). The systems are designed in a peculiar way to produce Purified Water (PW), Ultra Purified Water (UPW), Water for Injection (WFI) and Pure Steam (PS). And Ultra Purified Water (UPW) for semiconductors.
Pre-treatment options, operation and maintenance requirements, monitoring of critical parameters, consumptions, microbiological control, operation and maintenance requirements, as well as the lifecycle costs are key points in the selection of the proposed equipment.
FORMULATION AND PROCESSING
We commercialize complete Formulation & Preparation Plants, starting from specific product and market objectives. Sterile preparation or cleaning and sterilization of process vessels or contact equipment are common issues in the pharmaceutical industry and therefore a must in any of our specific supplies.
Specific manufacturing of solutions or sanitization & sterilization requirements can be satisfied by our processing systems, providing the optimum balance of performance with cost effective.
Aseptic processing equipment includes, e.g.: Mixing Tanks and Bioreactors, Mixing Vessels, Pressure Tanks / Pressure Vessels, Customized Formulation Tanks, Mobile Mixing Vessels, Atmospheric Transfer Tanks, Cip/Sip Systems, Customized & Mobile Stations, Ancillary Systems, Filtration Groups and Solution Transfer Circuits, Loading Platforms, Laminar Air Flow Cabinets.