Pharmaceutical Isolator

Isolator : Product Description

Pharma isolator is generally in the clean room of Class C or D level, pharmaceutical isolator creates a controlled atmosphere during the production process by scrupulously respecting the different standards required. It can ensure the protection of the product, the operators and the environment at the same time. Isolators provide full containment of highly active and/or sterile compounds thus offering both operator and product protection.

The pharmaceutical isolator is a bacteriologically sealed enclosure used in the medical and pharmaceutical environment for toxic processes and aseptic filling process. It is made of a perfectly sterile main isolator where the products are handled, stored or packaged using shoulder-high gloves placed on one of the walls. It also includes transfer systems that allow the entry and exit of the products and the elimination of waste without breaking aseptic conditions.

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More Details of Pharmaceutical Isolator

Containment Dispensing Isolator

The Senieer Dispensing Containment Isolators are advanced containment systems providing controlled negative pressure environments to maximize personnel protection during dispensing of potent compounds. It provides standard configurable designs that are able to adapt to various dispensing quantities and accuracies. The isolator is also equipped with a special CIP system. Humidity and temperature probe inside the chamber for monitoring as per requirement. ① Inflatable antibacterial, USP Class VI compliant and food grade FDA approved gaskets providing both proactive and reactive sealing ② Safe change glove system allowing change of gloves whilst maintaining a contained system ③ Integrated anti-vibration granite platform for analytical balance placement ④ Integrated automated pressure decay testing ⑤ Clean interior and exterior finishing ⑥ Safe change filters to allow in-process filter replacement ⑦ Lighting external to isolator chamber for ease of servicing and process chamber cleanliness Integrated automated height adjustment providing for ergonomic comfort

Laboratory Containment Isolator

The Quality Control HPAPI isolator is designed to perform high containment for fine particle size products and operations. Isolators are a core component to the pharmaceutical industry, critical for a range of processes. Senieer manufactures advanced cGMP-compliant isolators to protect products, personnel and the working environment. Isolators are customized to meet the rigorous demands of your specific application and operate under negative pressure. GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for analysis/quality control activities. Maximizing operator protection is the primary characteristic of a Laboratory containment isolator. Senieer assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA approved EPDM (Ethylene Propylene Diene Monomer) to guarantee air tightness Class II (ISO 10648:2). The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) filters. The isolator works at negative pressure (-100 Pa for airlocks and -150Pa for working chambers) to protect the operator: isolator chamber works under nitrogen blanketing. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment. Senieer provides Containment Solutions for All Types of Hazards – Chemical.

Flexible Film Isolator

The overpressure flexible film isolators are primarily used in the animal research field. The isolator is made of PVC film welded together and can be sterilized using a 2% peracetic acid solution. Interlocking cylinder locks can be used on either side of the isolator for the aseptic transfer of material. Neoprene gloves are assembled for easy working inside the isolator. The gloves are easily changeable in case one has a leak and needs to be replaced. Flexible films have been used to construct bacteria tight protective garments. A steam sterilized tank 8 ft in diameter and 15 ft long. The airlock and continuous liner features ensure containment during pharmaceutical production so you can create your product safely within Good Manufacturing Practice (GMP) standards. The air flow to and from the isolator is filtered via two-part stainless-steel cartridge filters. Two alternating current blowers are installed for maintaining the desired pressure within the isolator. Isolators have been used to provide a defined environment for maintaining animals, biological materials and microorganisms. Flexible plastic films are inexpensive and made readily into bacteria-tight structures. Their flexibility permits the transmission of limited movement through any portion of the wall without disturbing the contamination barrier. They can be sterilized either with a liquid germicide applied as a spray or gaseous germicides.

Sterility Testing Isolator/ Aseptic Filling Isolator

Sterility Test Isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity. They also provide a controlled means of loading and removing the processed product and waste materials from the Isolator enclosure. Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production batch. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results. False positive results are generally due to laboratory contamination from the testing environment or technician/technique error and cause additional work in terms of extra documentation required and adds significantly to cost as it delays or prevents release of the product for sale. ① The fully automatic and validated decontamination using H₂O₂ on the LOG6 level in order to prevent false-positive test results. ② The safe removal of the H₂O₂ before the test commences in order to prevent false-negative results. Sterility Test Isolators are designed to avoid the risk of false results and to protect the product from both the process and externally generated factors that would compromise its quality. Sterility Test Isolators provide a Grade A (ISO 4.8) positive pressure environment as either single pass directional flow or recirculatory unidirectional laminar flow designs. Manufactured to a high pharmaceutical standard from stainless steel with sealed glass vision panels, Senieer meets the high demands of GMP industry standards and stringent leakage criteria as required by ISO 14644-7. ① Transfer isolator segment TI for product and implements transfer ② Sterility testing isolator STI segment for conducting sterility tests ③ Alternative fogging systems also available (for select applications/cycle times) ④ In-room design for ease of installation and engineering management ⑤ Catalytic conversion for maximum personnel safety and faster cycle times ⑥ Environmental Monitoring Full documentation for cGMP compliance and qualifications

Weighing and Off-Loading Isolator

Our Drum Filling Systems provide refined containment and ergonomic designs that ensure effective and completely protected operations. Our Drum Filling Systems are specifically designed to suit requirements for operator exposure levels, product protection, cleaning regimes and powder properties. Our Drum Filling Systems system forms a series of powder handling systems, including: Vacuum Conveyance Transfer with Rigid Isolator（Flexible Isolator） Drum to Drum Transfer with Rigid Isolator(Flexible isolator) Drum to Bag/Bottle Transfer with Rigid Isolator(Flexible isolator)

Weighing and Dispensing Isolator

Weighing and Dispensing Containment Isolators are advanced containment systems providing controlled negative pressure environments to maximize personnel protection during weighing and dispensing of potent compounds. Senieer provide standard configurable designs that are able to adapt to various weighing and dispensing quantities and accuracies. The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) single stage inlet and double stage outlet filters. The system is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2). The inflatable seals are made of FDA approved EPDM (Ethylene Propylene Diene Monomer) manufactured. The isolator was designed to permit the dispensing and weighing activities of micronized highly potent substances (progesterone OEL 0,01 mg/m3). The system is provided with Integrated manual & automatic Wash-In-Place (WIP) for cleaning processes, thus improving safety for the operators involved in the production of potentially hazardous compounds and reducing the risk of possible cross contamination. ① Fully welded single-piece SS316L internal chambers with rounded coved corners ② Pressure tested to ISO 14644-7 ③ Inflatable antibacterial, USP Class VI compliant and food grade FDA approved gaskets providing both proactive and reactive sealing ④ Safe change glove system allowing change of gloves whilst maintaining a contained system ⑤ Integrated anti-vibration granite platform for analytical balance placement ⑥ Integrated automated pressure decay testing ⑦ Clean interior and exterior finishing ⑧ Safe change filters to allow in-process filter replacement ⑨ Lighting external to isolator chamber for ease of servicing and process chamber cleanliness ⑩ sensor for temperature and humidity internal monitoring ⑪ Magnahelic Manometers for the internal pressure control Inverter for ventilation fan speed control

Isolators with Vacuum Dryer

Senieer manufacture complete Vacuum Drying systems, we can customise our vacuum dryers where needed and have both circular and rectangular drying systems along with a vacuum pump system. Vacuum Dryers that are easy to use and consume less power than other traditional types of Dryers. We design Vacuum dryers from laboratory to production scale and can meet sterile process requirements when necessary for drying highly toxic or sensitive products. Our laboratory cGMP tray dryers provide a safe, hygienic and cost-effective small-scale tray drying solution when used with our isolator system range. ① Flexible Cost-effective isolator system ② cGMP - Designed for sterile & non-sterile processing ③ Full Vacuum and excellent heat transfer drying ④ Full pressure control with alarms ⑤ Clear visibility during operation and cleaning ⑥ Operator safe environment ⑦ Sterile substance processing ⑧ Drying of highly corrosive solvents ⑨ Pharmaceutical & Chemical substance processing ⑩ Fluid heating and circulating systems either steam or electrically heated, with PLC based process control possible ⑪ Vapour condensation unit along with a receiver ⑫ cGMP construction for pharmaceutical models. ⑬ Modular design reduces overall manufacturing costs and allows our S2 VTD's to be competitively price positioned. ⑭ Inclined bottom with integrated collecting pipe and discharge nozzle ⑮ CIP cleaning device for the repeatable cleaning ⑯ Carrier gas lance for the optimal distribution of the carrier gas via all shelves Wall installation brackets for the installation of the dryer onto a clean/lab room wall

Isolated Lyophilizer Loading

The growth of lyophilization and its complicated processes has challenged manufacturers to maintain safety for operators working with highly potent ingredients, which has created a demand to assure product quality and protection from contamination. Ranging from small lyophilization systems used for R&D to larger production systems, the ability to handle vials and trays is often an effort to minimize ergonomic stress as well as mitigating the risks associated with exposure and potential product loss. In a perfect world, containment is not needed for freeze drying product, but this is hardly the case when lyophilizing highly potent powders in bulk quantities. Especially with highly potent materials, any upset conditions during the lyophilization process such as the broken vials or the mishandling of product during the transfer process can pose significantly major risks of product cross-contamination, the operator’s health, and the environment in general. Isolation technology, whether being fixed or single use systems, mainly protects the product from cross contamination before freeze drying, as well as protects the operators and environment after freeze drying from any airborne HPAPI particles. Even though isolation technology is a must when dealing with highly potent products, there are many challenges to providing sufficient containment when working with a lyophilizer.

Micronising Containment Isolator

Senieer designs and builds a full range of Pharmaceutical Isolators including systems which are designed to achieve Occupational Exposure Limits (OELs) down to 10 ng/m3. These Micronizing containment isolator systems are used for operator safety and protection during ultra-fine micronization of dry powders such us pharmaceuticals, chemicals and cosmetics. Milling and micronization operations sometimes involve the size reduction of highly potent active pharmaceutical ingredients (APIs). The company’s system therefore needed to reduce the operator exposure level to less than 1 µg/m3 throughout the operation. The development of increasingly potent and potentially toxic pharmaceutical products and chemicals has led to demands for increased operator protection from exposure to harmful dusts. At this OEB level, the material is hazardous or highly hazardous hence significant measures should be taken to prevent operator exposure. There should be a physical barrier between the operator and the material. Isolators and Restricted-Access Barrier Systems (RABS) are common, whereby material can be openly handled inside the dedicated enclosure, with the operator manipulating the equipment and material externally through glove ports. ① Micronizer isolators are used for operator safety and protection during ultra-fine micronisation of dry powders, such us pharmaceuticals, chemicals and cosmetics. ② Micronization is frequently used in order to reinforce the solid forms % of the active ingredient or the particle size will create a barrier to the solubility of an active ingredient. ③ Micronisation is a proven technology of reducing the particle size of active pharmaceutical ingredients (API's) and increasing the rate the drug is absorbed and is therefore made available. ④ The particle size reduction is completed by the collision of the different components in the air ⑤ The process of reducing the average diameter of a solid material's particles involves techniques which include milling and grinding where modern techniques make use of the properties of supercritical fluids and manipulate the principles of solubility. ⑥ Micronisers are usually used in batch applications but can be used as part of a continuous process. ⑦ Micronisation must be carried out under cGMP conditions ⑧ Excellent internal visibility ⑨ Optional glove port positioning ⑩ Lightweight construction ⑪ Highly flexible in use as self-contained workstations ⑫ Integrated Clean In Place / washable to reach every corner of chamber ⑬ Stable and accurate results ⑭ Clear visibility during operation and cleaning ⑮ Operator safety - fully interlocked air-locks, doors and visors ⑯ Uncontaminated process media ⑰ Low pressure and high-pressure alarm Filter choked alarm

Glove Integrity Tester

The tester is attached to a flange and fills the glove to the required pressure using compressed air. When the sealing cap is placed over the glove-port ring, a space is formed between the cap and the inside surface of the glove. This space is then pressurised to 1000 Pa and allowed to stabilise. A drop in this pressure will indicate a leak through the glove fabric or securing arrangement. The most advanced GMP compliant glove integrity system for isolators and RABs in the pharmaceutical industry, developed in compliance with the international standard ISO 14644-7 Annex E5. ① No need for electric power supply ② Work with compressed air only ③ Refined ergonomic solution ④ User-friendly operation ⑤ Faster testing time: ranges from 8-10 minutes per glove, depending on both glove material and dimension. This results in fewer units needed for a testing period, and a large number of glove tests can be performed between each charge ⑥ Complete encrypted data/reports storage and download via SD card or USB ⑦ There are no external connections needed ⑧ Manufacturing materials are resistant to sanitizing agents and bio-decontamination processes ⑨ Automatic complete testing procedures ⑩ Saving production time in isolated filling lines, stand-alone isolator systems, and Restricted-Access Barrier Systems (RABS) Technology ⑪ Avoiding operator mistakes ⑫ Detecting small holes in the gloves (≥ 100 μm) ⑬ Data consulting can be done outside the classified environment

Any Question About Senieer Pharmaceutical Isolator

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Why Global Company Trust Senieer

Top Quality Factory Price

We have a quality control department to verify each product at different phases, from the procurement of parts to finished products

As Your Layout, Customize Machine

According to your layout, we can suggest the best capacity and type for you, customize pharmaceutical isolator for you

Pharmaceutical Isolator Consult & Design Service

Save energy resource for you, professional engineers can improve the best processing solution. We have the experience to help add a tremendous amount of value to your project

ISO.CE Standard Qualified

We successfully obtaining the ISO9001:2008 certificate and CE security management system certificate, this is significant for Senieer in building enterprise image

Pharmaceutical Isolator Training & Maintance Service

Free pharmaceutical isolator training & maintenance service for you, we will provide your team in-depth training on safe operation and pharmaceutical isolator maintenance

Pharmaceutical Isolator Installation Service

Senieer offers pharmaceutical isolator installation & commissioning service for production products, your pharmaceutical isolator and control systems are qualified based on the GAMP life-cycle

Pharmaceutical Bin Ultimate Buying Guide for Importers

Let’s dive right in:

In the synthesis of highly potent active pharmaceutical ingredients (HPAPIs) filtration and drying of the moist products is an important process step where isolators can be recommended for optimal workplace safety and full recovery of the expensive materials.

Many of the drugs handled in the isolators are designed to fight cancer cells and, as such, would be dangerous if they came into contact with a healthy individual. Therefore, the isolator’s role is paramount in the safe manufacture of such products.

To ensure that the products are manufactured with the correct background air, isolators require effective, corrosion-resistant ventilation of the process area. The isolators are designed to not only protect the operatives carrying out the task, but to also protect the substances within the chamber. The inbound air is highly filtered to provide a clean atmosphere and minimise the risk of contamination of the medicine or matter being tested.

Active Pharmaceutical Ingredients (API) have the prospect to bring about severe to serious health effects in personnel at very low airborne concentrations. The use of containment systems or equipment, as an integral part of an efficient method to potent compound safety, is recommended to control personnel exposure.

APIs can be classified into control bands based on their potency. Generally, APIs are categorized by occupational exposure limit (OEL) as a classification measure.

Chapter 1: Terms:

OEB – Occupational Exposure Band is a mechanism used to precisely assign chemicals into “categories” or “bands” based on their adverse health outcomes and potency considerations. It also aligns chemicals in groupings based on OEL in order to establish safe handling guidelines.

*Almost every facility has their own version

Chapter 2: Hazard Banding (OEB) Criteria:

These include qualitative, semi‐quantitative, and quantitative data for each toxicological endpoint.

▣ Acute toxicity

▣ Skin corrosion/irritation

▣ Serious eye damage/eye irritation

▣ Respiratory and skin sensitization

▣ Germ cell mutagenicity

▣ Carcinogenicity

▣ Specific target organ toxicity, both single and repeated exposure

▣ Reproductive toxicity

OEL – Occupational Exposure Limit is the airborne concentration of a compound to which nearly all workers can be repeatedly be exposed to for 8 hours a day, 40 hours a week, without adverse effects.

Exposure limits determine manufacturing safeguards
Occupational Exposure Limit	Band	Production Requirements
>1 – 10 mg/m³	1	Good manufacturing safeguards
>0.1 – 1 mg/m³	2	Good manufacturing safeguards (with local exhaust ventilation)
>0.01 – 0.1mg/m³	3	Essentially no open handling (ventilated enclosures required)
>0.001 – 0.01mg/m³	3+	Virtually no open handling (containment systems required)
≤0.001 mg/m³	4	No open handling (closed systems required)
≤0.001 mg/m³	5	No manual operations/human intervention (robotics or remote operations required)

Chapter 3: Each application must be assessed based on the following criteria:

▣ Product dustiness – the smaller the particle size the more likely it is the powder may get airborne.

▣ Type of product – if the product is cytotoxic/genotoxic and the requirement is in the 1-5 microgram range, consider full containment (isolator) unless the quantity/process is not practical for full isolation. If full isolation is not practical, operators should use additional protective equipment (full air fed suit) and the downflow booth room access must be via an airlock.

▣ The process – if the process imparts high energy to the powder, such as milling.

▣ The time taken to carry out the process – the longer the process time, the higher the potential risk of exposure.

▣ The quantity of powder handled at any one time – the higher the quantity, typically the higher the risk (bearing in mind the above, that is if the powder is granular i.e. sand like, the risk may not be that high).

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