Taishida Pura Aseptic Testing Isolator

Main characteristics

• Air grade: All chambers ISO Class 5 (EUGMP Grade A)
• Airflow mode: Unidirectional turbulent or laminar flow in all compartments
• Lighting level: Test chamber 700Lux, transfer chamber 300Lux
• Noise level:<70dBA
• Imported filtration: HEPA H14 high-efficiency filter with a filtration level of 99.997%
• Exhaust filtration: HEPA H14 high-efficiency filter with a filtration level of 99.997%
• Pre filter: E10 pre filter is used to protect the upstream inlet filter
• Biological purification: It can achieve a minimum sterilization level of log 6 for spore like microorganisms, verified through the use of thermophilic fat loving Bacillus biological indicators
• Sterility test pump bacterial collector
• The standard configuration of the Taishida bacterial collector is Millipore or Sartorius, which can be integrated at the bottom of the isolator according to GMP requirements
• Non Viable dust particle monitoring
• ① APEX P5 air particle counter, portable air particle counter, equipped with a printer and a 3.5 "color touch screen, with a casing made of 304 stainless steel material. Can count 2 channels simultaneously and support 3000 data records
• ② Equipped with LMS Express data transmission software, data can be collected through user's PC operation, in compliance with 21 CFR Part 11 data security regulations
• Viable planktonic bacteria monitoring
• Sartorius MD8 airscan air monitoring device; Can be used in conjunction with the highly trusted Gelatin membrane filtration method
• Indoor monitoring
• The monitoring of hydrogen peroxide is achieved through a single channel hydrogen peroxide sensor. Used to test the concentration during sterilization, with a testing range between 0-300ppm
• H₂O₂ Monitoring outside the cabin
• Used to detect the hazardous level of H2O2 outside the isolator. When the concentration of H2O2 in the room reaches a dangerous level

Closed isolator system
Product Introduction

1. Taishida Pura Aseptic Testing IsolatorThe design and manufacturing standards of the product are always consistent with government regulations and industry standards to adapt to constantly changing industry demands.
2. Faced with the increasing demand and challenges of sealed isolation equipment in the pharmaceutical industry, Taishida is committed to providing professional solutions for customers' personalized project needs.
3. Sealed isolation has become an increasingly important part of the pharmaceutical process. A clear understanding of the customer's process is the key to our success.
4. Taishida UK Limited is the production base of Taishida Group's isolator system equipment. Our attention to detail sets our design proposal apart.

Product Features

1. Taishida always pays attention to the growing demand and challenges of the pharmaceutical industry for sealed isolators, and is committed to providing effective solutions for various sealed isolator projects.
2. The processing of PAPI/API powder products is a constantly challenging field, especially in terms of protecting operators during operation.
3. The production of small batches of highly active intermediates and active ingredients in the laboratory often requires a series of process equipment to perform corresponding process operations, such as filtration and formulation.
4. The isolator can be integrated as a whole with laboratory glass reactors and matching stirring motors, glass condensers, cooling/heating devices controlled by thermostats, and evaporators equipped with vacuum pumps. Fully compliant with GMP requirements, operators can carry out all process operations through highly sealed isolators without the need for related industrial operations in clean rooms, reducing the time required for the purification clothing on and off procedures.
5. The non-standard customized liquid distribution isolator is integrated with the back enamel reaction kettle, and the operator stands on the operating platform near the glove end hole. The integrated internal weighing system and external tank weighing sensor can weigh powder products before they are put into the reaction vessel.
6. Partial liquefied products may be harmless to operators before the freezing process, but due to their toxic components, they may be harmful to operators after freeze-drying into powder. The integrated connection with the sealed isolator becomes the most important protective measure for the operator.
7. The pallet storage and transportation vehicle is used to transport high-pressure steam sterilized pallets to the packing/feed loading integrated with the isolator, as well as to recycle used pallets.
8. The Automatic Tray Loading/Unloading System (ATLUS) from Taishida is used to load trays filled with liquefied products into the Taishida freeze-drying chassis.