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Parenterals containment Equipment

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to parenterals, we are referring to those dosage forms that are administered directly into the bloodstream using a hypodermic needle, avoiding going through the gastrointestinal tract. Using parenteral filling equipment, parenteral solutions are placed in containers such as vials, syringes, or ampoules.

Parenterals

Provides the highest levels of operator protection from potentially harmful airborne contaminants generated during manual powder handling operations such as sampling, charging and dispensing.


<h2>Remove airborne particles from the operator's breathing zone</h2>
The downflow booth from Telstar Life-Science operates on a re-circulatory airflow principle. Clean laminar flow air is supplied from the ceiling, suppressing any dust clouds generated during any processing operation and removing airborne particles from the operator's breathing zone (OEL &lt; 100 µg/m3).

The fact that the booth works with a net inward airflow, ensures airborne contamination cannot escape into the external environment completing the many advantages of this effective containment system.

Down flow booths are frequently used in Pharmaceutical, Cosmetic, fine Chemical, Food and Nanotechnology industries.

Downflow booth

Designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.


<h2>Perform sterility testing in an aseptic environment providing assurance of material integrity</h2>
The Sterility test isolators from Telstar Life-Science range of rigid wall Sterility are designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.

Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot. 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.

It is suitable for performing both Direct Inoculation and Filter Membrane sterility tests with flexibility to be bio-decontaminated by different types of bio-decontamination systems available.

Sterility test isolators

HEPA filtered vertical laminar airflow (down flow) creates an ISO 14644-1 (Class 5) work area and prevents ambient air entering the work area, ensures product protection.


<h2>Create a class 5 work environment for non-hazardous materials</h2>
Telstar vertical clean benches ensure optimum product protection with HEPA filtration. Heavy duty construction and reliability make them convenient in the long term for all sectors of application and environments. Vertical laminar flow cabinets can be made in special sizes and can be customized to suit particular applications.

Special models have been developed to create the optimum work environment for PCR (polymerase chain reactions) and for lab environments. Down flow booth models are available that work fully with recirculated laminar HEPA filtered air (Telstar V-100) or partially recirculated laminar HEPA filtered air (Telstar V30/70).

Vertical laminar flow cabinet

HEPA filtered horizontal laminar airflow (crossflow) creates an ISO 14644-1 (Class 5) work area and prevents ambient air entering the work area, ensures product protection.


<h2>Particularly well adapted to hospital, control laboratories and life science environments</h2>
Horizontal Laminar Flow benches from Telstar Life-Science have a wide and high working space with a continuously flushed frontward by a particle free HEPA filtered and laminar airflow; which speed prevents contamination from operator and lab environment. The laminarity of the flow prevents cross contamination between the items handled in the working space.

Offering the highest product protection possible in an open system. It makes them particularly suitable for the handling of non-hazardous products, sensible to dust and/or to contamination such as injectable medicines, cell and tissue cultures, food sample preparation for sterility testing as well as micromechanics, optics, electronics.

Horizontal laminar flow benches

HEPA filtered horizontal laminar airflow (cross-flow) creates an optimized free space for manipulation with ISO 14644-1 (Class 5) conditions.


<h2>Compact booth that offers easy access to manipulate non-hazardous products</h2>
Mini-H from Telstar Life-Science are Horizontal laminar flow benches which offer the highest product protection versus dust and contamination in an open cabinet for non-hazardous samples such as cell and tissue cultures, food testing preparation, injectable medicine preparation. It also fits for micromechanics, optics and electronics.

The Compact horizontal laminar flow bench comes with HEPA filtered air; it's particle free and flushes the product preparation space with laminar flow, preventing direct or cross-contamination.

Thanks to its very compact size, Telstar Mini-H permits the installation of a product protection cabinet near the place where the product is utilized.

Compact horizontal laminar flow bench

This handy device offers the most advanced features in product-operator protection and user-friendly ergonomics to allow best working conditions and results.


<h2>Protect to the operator, product/materials and environment under class II conditions</h2>
BioULTRA from Telstar Life-Science is a top range class II cabinet aimed to provide protection to the operator, product/materials and environment. It is certified according to European Standard EN 12469 and also meets NSF 49 (class II type A2 /B3) and BS 5726:2005 main requirements. It is suitable for handling pathogenic agents of levels 1, 2 and 3 in the fields of pharmaceutical, academic research centers, biotechnology, hospital and medical labs, QA control labs.

Motorized sash window with inflatable gasket, filter clogging calculation and a simplified fumigation process minimize maintenance cost and time.

Remote PC Ultra logger control suitable for P3 lab.

Microbiological safety cabinet class II

For the manipulation of hazardous substances utilized during the preparation of cytotoxic medicines as prescribed in several European countries.


<h2>Ideal class II configuration for reinforced biosafety and maintenance cost savings</h2>
The CytoUltra from Telstar Life-Science has 3 filters, which third HEPA filter set below the work bench of CytoUltra traps the contaminants thus preventing them from reaching the plenum, the main HEPA filter and the HEPA exhaust filter, such reinforced safety is required for the handling of highly toxic compounds.

Certified EN 12469 Class II and DIN 12980 for Cytotoxics, CytoUltra offers the most advanced features in product and operator protection and in ergonomics to allow best working conditions.

Third HEPA filter stage easily replaced in the unit basement and filter clogging calculation minimize maintenance cost and time. Remote PC Ultra logger control is suitable for P3 lab.

Biosafety cabinet class II for cytotoxic medicines

Ideal for products which have no biological risk but require high sterile conditions.


<h2>Start working in the lab under high sterile conditions</h2>
Sterilator from Telstar Life-Science is a positive-pressure isolator, which provides laminar airflow in the working chamber, making it ideal for products that require high sterile conditions.

This equipment not only provides a high level of containment against external contamination, but avoids the risk of cross contamination as they provide laminar air flow to the working chamber.

Positive pressure isolator

Specially designed for the handling of microbiological agents, when working with indigenous or exotic pathogenic agents that pose a moderately high risk of serious or potentially lethal disease to the operator when inhaled.


<h2>Offering Class III biological safety to operator, product and environment</h2>
The Biological safety cabinet class III from Telstar Life-Science is a laboratory isolator designed according EN 12469, offering an ergonomically designed totally sealed which keep the user completely separated from the product by a physical barrier when total containment and user protection is required.

Series MSC III is a completely gastight cabinet. The dangerous biological agents enter the work area by a hatch, the operator uses gloves (assembled to the front of the cabinet) to research the biological agents. While working, potential contaminated air is controlled by airflow and negative air pressure.

Biological safety cabinet class III

Used for products biologically hazardous, that also require minimized cross contamination.


<h2>Start working with hazardous substances thanks to this perfectly adapted device</h2>
The Cytolator from Telstar Life-Science is a negative-pressure isolator, which works providing laminar airflow within the working chamber while ensures a minimum of cross contamination. The Cytolator main chamber pressure (vs. ambient) is negative to the room. Both the main chamber and pass-through are always negative to the room, and provide protection to the product, user and environment.

An additional third HEPA H14 prefiltration stage right below the workbench adapts the isolator to the requirements in the manipulation of hazardous substances like the preparation of cytotoxic medicines as prescribed in some countries recommendations.

Negative pressure isolator

Sterile filling of liquids and powders for the pharmaceutical and cosmetic industries requires flexible automation to accommodate format changes and optimize production. Also, vial sizes can range from 0.1 ml to 500 ml and syringes from 0.1 ml to 20 ml.
<h2>Fill, stop and crimp syringes and vials of all sizes</h2>
XI-I is specially designed by i-Dositecno for pharma filling, able to fill sterile liquid and powder in doses from 1 to 500 mls into vials and syringes.

4,000 units per hour can be produced for formats up to 80 mm diameter in a simple configuration, while 7,000 units per hour can be attained for smaller units up to 26 mm diameter in a double configuration.

Filling is by means of peristaltic pump, stainless steel rotary pump, ceramic rotary pump or CIP/SIP rotary pump. Stoppers are introduced by pick and place and capsule introduction and crimping are also completely servo driven.

&nbsp;

Sterile filling line for injectables

For smaller-scale production of vials and syringes for the injectables market, sterile conditions and accurate metering are still required for filling, stopping and crimping a wide range of container sizes.
<h2>Fill vials and syringes in basic, yet flexible, configuration</h2>
The i-Dositecno MI-I is specially designed for sterile pharma filling, able to fill sterile liquid and powder in doses from 1 to 500 mls into vials and syringes.

3,000 units per hour can be produced for formats up to 80 mm diameter in simple configuration, while 6,000 units per hour can be attained for smaller units up to 26 mm diameter in a double configuration.

Filling is achieved by means of peristaltic, stainless steel rotary, ceramic rotary or CIP/SIP rotary pump. Stoppers are introduced by servo-driven pick and place, however, capsule introduction and crimping heads are controlled by pneumatics.

&nbsp;

Start-up sterile filling line for injectables

Where a compact solution is required for filling vials for the injectables market, sterile conditions and high-quality metering still need to be maintained.
<h2>Space-saving fill, stop and crimp line for vials</h2>
The table top BI-I from i-Dositecno can fill sterile liquid and powders in doses from 1 to 500 mls into vials, as well as specialized micro-dosing.

It can produce up to 2.000 units per hour for injectable vials from 2R to 500H as well as install rubber stoppers ranging from 12 mm to 32 mm and alu-caps 12 mm to 32 mm in size.

Filling is achieved by means of a peristaltic pump or a servo auger filler for micro-dosing which can meter as little as 0.150g. Stoppers are introduced by pneumatic pick and place and alu-caps loaded by chute, with crimping performed by pneumatics.

&nbsp;

Table top sterile filling line for injectables

<span style="font-weight: 400;">Pharmaceutical production techniques often require isolation of compounds and chemicals from an external environment and operators to preserve sterility, and/or to protect operators from contact with toxic compounds. CRABS and Isolators can be used with toxic and non-toxic compounds, and as standalone equipment in R&amp;D and lab settings. Also, isolators can be used as fully configured enclosures as part of an aseptic production line. </span>
<h2>Flexible in-line barrier systems for aseptic production</h2>
<span style="font-weight: 400;">The Steriline range of CRABS and Isolators offers the ideal flexible solution for containment in a pharmaceutical production environment. </span><span style="font-weight: 400;">Steriline closed Restricted Access Barrier Systems (cRABS) are designed for the production of any sterile products, toxic or non-toxic. They provide protection for operators from the product and protection for the product from operators by fully enclosing production areas.</span>

<span style="font-weight: 400;">Inside, HEPA-filtered, unidirectional air flows vertically over the process area. The pressure difference between the interior and the exterior is maintained by the exhaust fan which is HEPA-filtered by “Bag-in Bag-out” (BIBO) filters.</span>

<span style="font-weight: 400;">Steriline Isolators can be installed in Class C or D rooms. For in-line use they are custom-designed to complete a fully integrated aseptic production line, in compliance with all cGMP, GAMP and 21CFR Part11 regulations. They maintain uncompromised, continuous isolation of the unit interior from the external environment to ISO5 standards. This is achieved by using HEPA-filtered, unidirectional air that vertically flows over the process area. A pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is then HEPA-filtered by BIBO filters.</span>

<span style="font-weight: 400;">Steriline CRABS and Isolators are designed to provide a maximum 2% leak rate and offer continuous automatic pressure monitoring and control. With LED lights for improved illumination and an integrated VHP generator they offer the perfect isolation solution for aseptic production.</span>

Closed restricted access barrier system

<span style="font-weight: 400;">Bespoke aseptic isolators designed for production environments don’t meet the needs of small-scale uses. For compounding, quality control, sterility testing, dispensing, weighing or R&amp;D work, a standalone Isolator can offer the best balance between features, flexibility and cost. </span>
<h2>Standalone Isolator for lab and QC use</h2>
<span style="font-weight: 400;">The Steriline Standalone Isolator is designed to work with sterile products, either toxic or not-toxic, and grants the highest safety levels for both product and operator. </span><span style="font-weight: 400;">Practical features include stainless steel walls with high level surface finishing for ease of cleaning </span><span style="font-weight: 400;">and sanitization, and an optional integrated VHP (Vaporized Hydrogen Peroxide) generator for the sanitization cycle.</span>

<span style="font-weight: 400;">Standalone Isolators maintain an ISO 5 with either unidirectional or turbulent air flow according to your process needs. The isolator is equipped with fans and HEPA filters to supply sterile air, and exhaust air is also filtered by “Bag-In-Bag-Out” HEPA filters with easy access for maintenance.</span>

<span style="font-weight: 400;">RTP ports enable In-Out product and waste transfer without compromising safety or risking sterility failure. Full cycle automation is controlled via touch screen HMI, with control and visibility on production, decontamination, and aeration phases, as well as integrity testing and maintenance. </span><span style="font-weight: 400;">With a 2% or less leak rate, Steriline Isolators are engineered to be fully compliant with all relevant cGMP, GAMP and 21CFR Part11 requirements.</span>

Compounding aseptic isolator

<span style="font-weight: 400;">Hospitals and compounding centres have traditionally used manual aseptic compounding processes. As well as being labour intensive, these also allow for the introduction of human error, both into dosing and mislabelling, and potential for breaching sterility. A 21st century automatic aseptic compounding system using robotic and RFID technology overcomes these problems at a stroke, increasing productivity, reducing lead times, and guaranteeing dosing accuracy and traceability.</span>
<h2>Complete robotic aseptic compounding system</h2>
<span style="font-weight: 400;">Steriline’s ACS Aseptic Compounding System is a computer-controlled system for compounding intravenous doses into IV or other containers within an ISO 5 environment. It has been designed for use in hospitals and compounding centres, and operates in accordance with all appropriate regulations, including labeling in accordance with industry “best practice” standards.</span>

<span style="font-weight: 400;">The ACS can handle both hazardous and non-hazardous medication, and can be used for both patient specific and batch production. Based around tried and tested Isolator technology, ACS includes vaporized hydrogen peroxide (VHP) sterilization as standard. This means it can be installed in an ISO 8 background environment, as per GMP Annex 11.</span>

<span style="font-weight: 400;">The ACS uses cutting edge automation and robotics technology to remove the need for human intervention to:</span>
<ul>
 	<li><span style="font-weight: 400;">Sterilize all items with (VHP) prior to compounding;</span></li>
 	<li>Calculate all conversions between weight and volume;</li>
 	<li>Reconstitute powder drugs with the appropriate fluid;</li>
 	<li>Dilute liquids to required concentrations;</li>
 	<li>Remove excess liquid from IV bags and bottles;</li>
 	<li>Compound doses into empty containers (including syringes, IV bags, and elastomeric infusors);</li>
 	<li>Manage in-process waste.</li>
</ul>
<span style="font-weight: 400;">Safety is paramount, and the Steriline ACS features a raft of features to ensure environmental, operator and patient safety, including ISO5 isolator technology; access restriction systems; zero cross-contamination risk operation; complete identification of all items via combination of vision, RFID and barcode systems; guaranteed traceability.</span>

Sterile compounding system

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