A TURNKEY VISION SATISFYING YOUR MARKETING NEEDS

Working for a highly competitive industry in all the American continents, we offer reliable turnkey projects & systems to produce IV Fluids, Dialysis and Parenteral Solutions.

With excellent experience on field, we care for your marketing. We bring you the latest technologies and knowledge, making your decisions more agile and appropriate.

American Pharma Technologies

A HOLISTIC VISION TO GIVE YOU THE RIGHT SOLUTION

Thanks to a complete range of experiences gained in pharmaceutical fields, our staff grants high competence for a wide series of issues that each company has to face, such as to program a new business or extend, revamp an existing production.

Our specific competence and choice in pharmaceutical equipment manufacturing brands -from water treatment to processing and filling for bags, vials or bottles- lead to conceive dedicated supplies, “trouble-free” in any storage or distribution stage, as well as in filling and packaging.

CFR21 Part 11 compliances, process analytics, process monitoring, production plant information systems, unit operation control and optimization are the baseline of the benefits we offer. Our solutions have been worldwide approved by the FDA, EMA, ANVISA, COFEPRIS, ANMAT, IMBIMA.

American Pharma Technologies

GOOG MANUFACTURING PRACTICE. IT’S OUR KEY.

The standards for good manufacturing practice (cGMP) require special care on risk assessment and verification procedures.

The Validation Master Plan we provide makes 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.

APT Validation Plan

This holistic vision is a key strategy to obtain flexibility, efficiency and convenience in small or large volume parenterals and in a wide range of products such as but not limited to:

– STANDARD IVF & ELECTROLITES

– DIALYSIS SOLUTIONS

– TPN (Total Parenteral Nutrition)

– SPECIAL SOLUTIONS

APT Pharmaceutical Solutions

 

American Pharma Technologies

OUR USUAL SCOPE OF SUPPLY

FEASIBILITY STUDIES
BASIC & ADVANCED ENGINEERING
– Architectural
– Clean Rooms
– Water Systems
– Process
EQUIPMENT
– Water Systems
– HVAC and Air Systems
– Solution Preparation Systems
– Filling, Inspecting, Packaging Systems
– Sterilization Systems
– Quality Control
CONTROL SYSTEMS
– SCADA
– BMS
– Complete Software Architecture
SITE ACTIVITIES
– Supervision & Project
Management
– Pipes welding & Inspections
– Installation
– Training
– Calibration
– Validation
– Commissioning
– Site Acceptacne Tests
– Start Ups
VALIDATION SUPPORT
– Validation Master Plan
– Validation Protocols
– Standard Operating procedures
OPERATIONAL SUPPORTS
– Regulatory Filing Support
– Regulatory Filing Support
– GAP Analysis
– Raw Materials & API audit

66 White Street – 5th Floor – New York City – NY 10013

+1.3475756633

 

 

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