PharmaLytica 2021 Hyderabad review.

Auger Type Powder Filling Machine designed by GMP

Auger type powder filling machine is suitable for free flowing and dry powder. These machines consume less power and serve diverse application the industries.

Brief description

AP-IS is a GMP Class A (ISO 5) modular isolator system, which has been designed for QC Labs, Pharmaceutical Production, and Pharmacies.

The high level of aseptic conditions achievable within in isolated environment makes the AP-IS isolator the perfect flexible equipment for different applications, such a Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer.

The base isolator is composed of a single 4 gloves working chamber, but additional chambers and/or air locks can be also supplied upon request as option.

The isolator system is equipped with an unidirectional air flow system, and constantly guarantees a pressure gradient between the chamber(s) and the lab environment.

The advanced performances of the ventilation system are guaranteed by the exclusive automatic pressure & air flow control system developed by Tema Sinergie over the years; this system also permits to operate the isolator system in either positive or negative pressure with a simple switch of the software set-up parameters.

The high air quality isolated environment is assured by High Efficiency Particulate Air (HEPA) pre-filters, and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters.

AP-IS is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2); the seals are made of FDA approved white silicon compound that contains anti bacteria inhibitors that prevent surface growth of micro organisms, and may achieve remarkable LOG reductions.

The AP-IS isolator system being based on a modular concept, any of the listed options might be added to a later date as further implementation of the module: Integrated gaseous hydrogen peroxide generators, Gaseous hydrogen peroxide sensor for TLV environment, Gaseous hydrogen peroxide sensors for chamber(s), Rapid transfer ports and transfer container, Integrated sterility testing pumps, Integrated viable & non-viable monitoring systems, Integrated glove leak tester, Integrated 21 CFR part 11 paperless graphic recorder, Integrated thermal printers, and Uninterruptable Power Supply (UPS).

Features

·         No container, no filling system.

·         Branded makes clutch break system use in filling head.

·         Branded makes pneumatic components use in machine

·         Fill size - 5 grams to 500 grams with the help of different size auger and Funnel.

·         VPHP resistant anemometer and humidity & temperature (rH%+T) sensor

·         Handles with integrated safety switch

·         LED lighting system

·         External monolithic control module made of stainless steel AISI 304

 

Technical specification:-

·         Output – Head wise different speed of machine (approx. 40 to 120 per minute)

·         Power –

·         Mirror Brite internal finishing (<0.3 µm) and Scotch Brite external finishing (<0.8 µm)

·         Weldings ground, smoothed, and polished

 

Some advantages of using isolator systems compared to the traditional cleanroom:

·         GMP Class A ISO 5 contained enclosure

·         Recirculation unidirectional flow airflow system

·         Integrated Gasified Hydrogen Peroxide Bio-decontamination Systems

·         Controlled reliability of the process

·         High quality product with total efficiency

·         Increased safety by reducing contamination risks, and consequently increased patient safety

·         Full process equipment integration

Description: Operator

Auger Type Powder Filling Machine designed by GMP

 

https://acicmachinery.com/aseptic-processing-isolator-system/#AP-IS-Documentation-Validation

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