WHITE PAPERS & CASE STUDIES

PRODUCTS & SERVICES

Restricted Access Barriers (RABs) were developed to enhance pharmaceutical aseptic processes carried out in conventional clean rooms. Extract Technology customer RABs are designed to fully comply with our customers’ requirements for aseptic pharmaceutical processing.

The FOF steam sterilizer series is the synthesis of Fedegari’s approach: work hard to create simplicity to you, without compromising performance. Fedegari guarantees the highest performances thanks to its experience and daily work with customers: engineering solutions, developing software and components.

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

The FCIS pharmaceutical isolator have been designed primarily for: Pharmaceutical dispensing/handling of API and High Potent Ingredients; Assure sterile continuity after unloading sterile process machines; and Guarantee aseptic filling during manufacturing phase.

The ILC Dover Continuous Liner is an easy-to-use system that has been proven effective in containing active pharmaceutical ingredients and other hazardous compounds.

Pharmaceutical and Biotechnology processing equipment can be made residue-free clean with Alconox Critical Cleaning Detergents. Alconox, Inc. detergents are available worldwide with consistent formulations, certificates of analysis, ingredient toxicity data, shelf life information, residue sampling techniques, ingredients disclosure, analytic methods, lot number tracking, and validation support.

Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.

The PharmaGard ES PR797 Compounding Pharmacy Isolator creates a recirculating positive pressure ISO Class 5 clean air controlled environment for aseptic compounding of non-hazardous drugs guaranteed to meet USP 797 compliance requirements.