What is Blow-Fill-Seal Technology?

This refers to advanced aseptic manufacturing in which the containers are formed, filled, and sealed in a single continuous automated system, within a sterile and closed area. It is mainly used to produce small (0.1mL) and large volume (500mL +) liquid-filled containers. Originally developed in Europe in the 1930s, it was introduced in the United States in the 1960s, originally used to food package and industrial products but over the last 20 years, it has become more prevalent within the pharmaceutical industry and is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.

The process of creating BFS involves several steps. Pharmaceutical-grade plastic resin is heat-extruded through a circular throat to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mold, and the tube is cut above the mold. The mold is transferred to the sterile filling space, mandrels are lowered and used to inflate the plastic to form the container within the mold. After the formation, the mandrel is used to fill the container with liquid. Once filled, the mandrels are withdrawn, and a secondary top mold seals the container. All actions take place inside a sterile chamber within the machine. The product is then discharged for labeling, packaging, and distribution.

What makes Blow-Fill-Seal technology an ideal solution for pharmaceuticals?

Firstly, it reduces human intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. It is widely used to fill vials for parenteral preparations and infusions, eye drops, and inhalation products. Secondly, the plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to form containers that are further sterilized by autoclaving as it has greater thermostability. Thirdly, there is a reduced risk of particulate delamination, which could be in the case a glass packaging. Fourthly, it is a flexible solution: the resins can be melted into any shape to create the container of choice. Lastly, it is ideal for transportation as it is lighter than glass and positively influences the weight of the shipment and there is a lower risk of breakage during transport.

Should I test BFS packaging for integrity?

As with the many advantages offered by BFS packaging, there could be some downsides too, like with all containers it is certainly worth testing for container-closure defects. The EU guidelines state that “containers closed by fusions, e.g., glass or plastic ampoules should be subject to 100% integrity testing”. Thus, inspection becomes fundamental. The inspection of each unit will result in a reliable, final product examination that can identify defective units (e.g. “leakers”). There are a variety of leak-inspection technologies in the market, such as the vacuum-decay method (VDM) and high-voltage leak detector (HVLD). The vacuum-decay method (VDM) is often selected for biological manufacturing because of its zero-impact on product quality. During vacuum decay leak detection, the test article is placed inside a chamber, which is then evacuated to a known pressure. If the product container exhibits a leak, the chamber pressure will rise at a rate greater than a predetermined baseline value.

What should I consider when evaluating in-line leak detection for BFS packaging?

One of the main challenges with in-line leak detection operation is the high false rejection rate. Due to the high temperature required for plastic extrusion, the ampoules, immediately after the BFS process, are notably warmer than room temperature. When the products are immediately passed onto a vacuum-detection chamber, the heat from the ampoule can cause a slight increase in pressure which the instrument may interpret as a leaky sample, which will trigger a false rejection signal. Therefore, it is highly advisable to have the product equilibrated to room temperature prior to subjecting the product to vacuum leak detection.

What solutions does Bonfiglioli Engineering provide to combat BFS packaging leak detection challenges?

Bonfiglioli Engineering follows the procedure of Vacuum Decay Method which is Approved industry-standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages” and approved by United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation” and EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products” ; PDA Technical Report No. 27 “Pharmaceutical Package Integrity” as well as EMA Annex 11.

Handling BFS leak-detection for zero false rejections:

The measurement system adopted by Bonfiglioli Engineering comprises of application of a pressure differential into an airtight testing group enclosing the container. The test objective is to detect container leakages by measuring the reached vacuum level. It also measures the vacuum change over test time, so that a correct interpretation of the test results can be given, reducing false rejections. The PK-VS is a non-invasive and non-destructive, 100% in-line Integrity Inspection solution for BFS containers. It offers an automatic drying system for zero testing chamber contamination and offers a speed limit of up to 220 strips/cards per minute for container formats from a minimum of 40 x 40 x 6 mm to a maximum size of 150 x 80 x 15mm. https://www.bonfiglioliengineering.com/products/pk-vs/ The batch control is fast, reliable, and repeatable. The quick format change offers versatility for diverse container sizes. All this comes with remote access for machine data and exchange and real-time display of testing cycle diagrams and raw data. It also offers an automatic head exclusion.

Bonfiglioli Engineering also offers laboratory equipment for small batch testing and for feasibility studies. The LFS-11 is a Benchtop CFR21 Part 1 Compliant CCIT solution that offers Vacuum Decay Testing for various container types, with its quick format change over, including one for BlowFill-Seal. It is also equipped with a Barometric Compensation System to avoid any vacuum level reading variations and provides records storage for maintenance and statistical raw data with easy, quick, and safe remote access.

Bahnson Photostability Reach-in chambers

The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products is an internationally recognized document referencing the need for stability testing.

The U.S. FDA has adopted the annex document Q1B, which states that products should be evaluated to demonstrate that light exposure does not result in unacceptable changes. Should changes occur, the drug manufacturer may reformulate or repackage the product to prevent further photodegradation.

In order to comply with the Q1B guideline of 11/96, the drug manufacturer is required to use one of two optional light sources (paraphrased):

Option 1: A light source designed to produce an output similar to the D65/ID65 emission standard referenced to ISO 10977. Such sources include full-spectrum fluorescent lamps, xenon or metal halide lamps. We offer a custom-made full-spectrum fluorescent lamp which combines visible and ultraviolet-A outputs.

Option 2: Light sources designed to expose both cool white and near-ultraviolet light. These include:

  • A cool white fluorescent lamp to produce an output similar to that specified in ISO 10977. BES offers a custom-made cool white lamp to specifically replicate this standard.
  • A near-ultraviolet lamp with a spectral distribution from 320–400 nm. with maximum emission between 350 – 370nm. Significant portions of UVshould fall in the bands of 320 – 360 nm. and 360-400 nm. BES also offers a custom-made ultraviolet-A lamp to meet these specific emission guidelines.

Conditioning System

Our precise air control system ensures conditioned air is distributed uniformly across your product shelves. A stainless steel impeller moves the air through the conditioning components within the enclosed plenum.

Air is then distributed and returned through the plenum’s sidewall ports which are specifically arranged for maximum uniformity and efficient thermal transfer. The conditioning system features include:

  • Temperature control to within ±0.2°C
  • Relative humidity control to within ±0.7% RH
  • Temperature uniformity of ±2.0°C
  • Relative humidity uniformity of ±5.0%

Cabinet Construction

Our double-wall chamber construction provides you with years of continued, trouble-free use. The interior is heliarc-welded at the seams to form a hermetic seal which prevents moisture from migrating into the insulation.

Each chamber size is proportioned to allow you ease of passage through a standard doorway. Construction features and options include:

  • Heavy-gauge stainless steel interior with scratch-resistant enamel on the exterior of the cabinet.
  • Closed-cell urethane insulation for superior high/low temperature stability and minimal heat transfer. The door is also completely foamed for thermal performance and rigidity.
  • Heavy-duty door hinges, full peripheral magnetic door gaskets, and positive action latch with a lock to maintain a secure, uniform seal.
  • Removable stainless steel plenum cover and wall air chases for ease in cleaning and maintenance.
  • Heavy-duty 2?casters (on floor models) and adjustable leveling feet for ease in installation.
  • Highly reflective specular metal wall coverings on all vertical surfaces.

Proportional Refrigeration System

BES incorporates a proportional liquid/hot gas refrigeration design to maintain close tolerance temperature control and rapid acceleration to your setpoint. The compressor life is extended by modulating refrigerant flow as required. All facets help maintain the life of your chamber under photostability conditions. The proportional refrigeration system features are as follows:

  • Air-cooled, hermetically sealed compressor with environmentally safe, non-toxic, CFC-free refrigerants. Optional water-cooled units are available.
  • Expansion valve refrigeration control provides higher heat removal capacity than conventional capillary tube designs and provides immediate response to added heat loads.

Lighting System

BES’ upright floor models provide up to (3) simultaneous light studies with adjustable, uniformly-controlled light levels across your product shelves. Intensities are easily and individually controlled at each light bank with a microprocessor-based controller and a photodiode sensor to provide a fully automated, closed-loop control system. The features of each light bank are as follows:

  • Automatic adjustment of lamp output to maintain intensities at varied conditions.
  • Interchangeable cool white, near-ultraviolet, full-spectrum, and dual source cool white/UV banks designed to meet Options 1 and 2 of current ICH/FDA guidelines. Three banks are accommodated in the upright floor model; one bank is provided in the benchtop model.
  • Independent light level and timing controls are provided at each individual light bank. Light bank timers provide precise testing durations.
  • Individual front reflector panels allow the chamber’s door to open without disturbing tests at other light shelves (floor model only).
  • Highly transparent light barrier for maximum transmission of visible and near-ultraviolet light while providing protection for the bulbs.
  • Stainless steel light bank shell with the specular aluminum interior for corrosion resistance and high reflectivity.
  • A shelf-mounted telescoping sensor is capable of accurate measurement and control of light levels through varied temperatures, product heights, and reflective conditions. Each light surface has a controlling sensor.
  • Precision, silicon photodiode light sensor custom-designed by ES and factory calibrated per NIST traceable standards.
  • Light level setpoint configuration in kilolux or watts per sq. m. with a digital light level display. Optional units are available on request.
  • High-frequency electronic dimming ballasts offer up to 20% more efficient than traditional electromagnetic ballasts.

We provide high intensity, uniform light levels through the use of optimum bulb positioning, highly reflective materials, and high output biax lamps. Extensive R&D has led to the unique bulb layout suitable for uniform exposure in 7-lamp, 4-lamp, and dual source operation. Special high-grade specular aluminum covers all vertical surfaces and provides ultimate reflectivity, resulting in excellent uniformity and higher light levels. The biax lamp design allows for 40 watt T-5 lamps to fit into a system normally capable of holding only 15–20 watt T-8 lamps. This means higher light levels and output per area than competitive light chambers. A popular feature of our lighting system is the dual-source light bank. This is standard on the benchtop model and available as an option on the upright floor model. Both cool white and ultraviolet-A lamps are integrated into one single bank and independently controlled by a corresponding light sensor for a total of two light systems at each shelf (shown above). Each source may be operated independently or simultaneously with light uniformity within ±10% in the standard 70% marked region (shown above).

Alarm/Monitoring System

Our control panel features standard high/low visual and audible alarms for temperature, humidity and lighting. The alarms offer you instant visual indication and time-delayed audible indication for quick notification. The temperature and humidity alarms automatically shutdown specific mechanical equipment. The alarm monitoring system features include:

  • Alarm silence function on all parameters with up to 60 minutes of delay time (individually adjusted for each parameter).
  • Standard N. O./N. C. dry alarm contacts for remote monitoring of each parameter. There is one temperature, one humidity, and one general lighting alarm.

Temperature Control System

Our user-friendly microprocessor-based control system incorporates a P.I.D. controller with a subpanel-mounted process board. This board features an L.C.D. backlit display and 4-function membrane switch pad. The system includes a digital setpoint and process display of your controlled parameters, while indicator lights monitor power and alarm functions. Non-volatile memory retains your setpoints for restart in the event of a power failure. All controls are mounted on a hinged access panel for ease of maintenance. Features include:

  • Temperature display configuration in °C or °F.
  • Precision, platinum RTD temperature sensor calibrated per NIST traceable standards.

Upright floor model control panel is shown with temperature and humidity control and optional three dual source light bank controls (6 total light systems)

Benchtop model control panel is shown with temperature and humidity control, standard dual source light bank controls (2 total light systems) and optional strip chart recorder

Humidity Control System

Our solid-state controlled electric steam humidifier maintains close tolerance humidity control. The humidity system features a direct-set microprocessor control with digital setpoint and process display for your ease of use and readability. High/low humidity capability is dependent on your model selection. See the Humidity Performance Curve sheet for specific ranges on each model. The humidity system includes:

  • High output vapor generator with float switch actuated solenoid fill system.
  • Dual refrigeration coil design for dehumidification at temperatures depicted on the Humidity Performance Curve sheet.
  • Humidity display configuration in % RH.
  • Solid-state variable capacitance humidity sensor calibrated per NIST traceable standards.

BSM FILLS TREATMENT FOR COVID-19 IN FEDEGARI ISOLATOR

Berkshire Sterile Manufacturing is working on the production of new drugs to treat COVID-19

BSM has just finished the first fill and is now looking forward to rushing the production of the experimental treatments to fight the coronavirus and help to save lives. Fedegari is proudly supporting the pharma industry in this challenging endeavor.

Using a Fedegari flexible isolator system to fill primary containers, Berkshire Sterile Manufacturing is tasked with manufacturing some of the first COVID-19 treatments to help those afflicted.

“We’ve been approached by three different companies. All three of which have been our clients and each of them have a COVID treatment,” said Andrea Wagner, BSM’s Senior VP Business Development.

“The COVID blocks the lungs from distributing oxygen to your body. These treatments are designed to open up your airways and get oxygen through”, completes Wagner.

Kinney explains, first of all,  that each of the three companies – who cannot be named due to confidentiality agreements – are approaching the problem from a different vantage point.

One of the drug molecules attacks inflammation. A second drug might be able to boost the immune system of COVID-19 patients. Finally, the third drug seeks to expand how much oxygen the lungs can take in.

“If they can boost the immune system of people they are hoping that some of them won’t get to the advanced stages of pneumonia. Regarding the third drug, it might help people having difficulty to breathe. If they can improve the oxygen uptake, likewise it will offer greater support in the later stages of the disease,” Kinney said.

Furthermore, BSM has also been approached by the US federal government asking the company to develop clinical material that could be used in a possible vaccine. Berkshire Sterile Manufacturing’s role in the process would be to sterilize material, then place it in vials and syringes so that to have it ready for clinical trials.

To discover Fedegari’s isolators and sterilizers, please visit fedegari.com or contact our representatives.


Why Consider An Unit Dose Packager?

Anytime medical professionals are able to streamline procedures, increase efficiency, and improve safety standards is beneficial to staff and patients alike. The introduction of unit dose packaging is one of the innovative ways that contract packaging companies helped the medical industry accomplish these goals. To gain the most benefits from single-use packaging systems, there’s no better option than to work with a reputable unit-dose packager.

Unit dose packaging is defined as, “a dose of medicine prepared in an individual packet for convenience, safety, and monitoring.” Based on this definition, it can be presumed that any unit dose packaging system must successfully improve safety, make monitoring more efficient, and be convenient for the users. LF of America proudly developed a form of unit dose packaging that meets these goals.

As a leading contract packaging and filling company, it is our commitment to continue innovating new solutions that elevate the industries we are fortunate enough to assist. Learn more about the various ways unit dose packaging has helped benefit hospitals and medical professionals below. If you’d like to speak with a unit dose packager about how our contract filling and packaging solutions can elevate you, contact LF of America for assistance.

Advantages of Unit Dose Packaging

To achieve the goals of creating a packaging solution that improves convenience, safety, and monitoring, we developed a unique single-dose packaging system. Using eco-friendly materials, our unit dose packaging design is a connected strip that contains five separate ampoules. Each unit is individually labeled using an easily identifiable and scannable code for electronic documentation. 

The ampoules can be safely separated without damaging the packaging, exceed regulatory safety standards, and can even be designed with a closeable seal for multi-use applications. The individual containers are also capable of being safely filled with varying products and customized using custom labeling, pad printing, hot stamping, or embossing.

Utilizing unit dose packaging makes it much easier for medical professionals and patients to administer the proper dose. It also benefits patients by giving them the opportunity to only pay for the medication they need instead of an unnecessarily large amount. 

The key advantages of our unit dose packaging designs include:

  • Improved safety for staff and patients
  • Removing improper dosing concerns
  • Easy monitoring through electronic documentation
  • Lower costs for patients
  • Easily locating containers that have been tampered with or damaged

LF of America is proud to offer turnkey contract filling services to our clients, including formulation, batching, and fulfillment. Our filling services are completed using state-of-the-art filling machines that exceed regulatory safety standards and industry practices. 

FCIS – PHARMACEUTICAL ISOLATOR

Fedegari has decided to develop the FCIS pharmaceutical isolator to offer its customers a process machine capable of:

  • Ensure maximum safety in the handling and dosing phases of active ingredients and high potent substances.
  • To ensure continuity of sterility when unloading from a sterilizer.
  • To ensure aseptic filling in the production of sterile drugs.

The FCIS unit physically separates the operator – who works in a class C or D EU cGMP (ISO7, ISO8 US cGMP ) environment – from the work chamber that ensures a class A Eu cGMP (ISO5 US cGMP ) environment. The isolator complies with FDA , EMA and WHO standards and associated pharmacopeias as well as all applicable EN standards and directives.

The FCIS pharmaceutical isolator has a side door for the passage of material and to remove any waste after the process. To avoid false positives, a standard FHPV peroxide generator is supplied, thanks to which it is possible to launch a cycle of chemical decontamination of the work surfaces before starting to use FCIS. This allows you to be sure of working in an aseptic environment.

Fedegari has installed on FCIS the same solution that is provided in the FCDV decontamination pass-boxes because the reliability of third-party generators was judged insufficient. A further advantage of the Fedegari peroxide generator is that it does not require proprietary consumables, reducing the running costs of the machine.

Thanks to the presence of sensors in the chamber, the concentration of the hydrogen peroxide vapor are directly monitored in real-time by the Thema4 process controller (against the estimate that is generally carried out by others) and remain constant in the chamber, ensuring certainty of results and repeatability of the process.

The Newman model S350 labeling machine

The Newman model S350 is a fully automatic, versatile labeling system for the application of both paper and clear self-adhesive labels to a wide range of cylindrical containers in glass, plastic, metal or composite materials.

The S350 has been specifically designed to meet the requirements of the international pharmaceutical industry and its regulatory bodies, including the FDA

Generally installed in-line, the S350 transports the containers along a conveyor and spaces them, using a scrolling feed, before they enter the labeling station. The label is applied and then immediately the container comes under the control of the applicator belt, resulting in precise registration and crease-free application.

Features

  • Compact cGMP Design
  • ‘Auto-teach’ label length facility
  • Digital scales for rapid container changeover
  • Positive accept security system
  • Fully validated security system with Critical Device Checking
  • Minimal change parts
  • High-performance stepper motor for label web drive
  • In-Process Control – system verification without production stoppages
  • Accurate label placement
  • Stainless steel 304 finish
  • Siemens or Allen Bradley PLC control system
  • Label coding options
  • Auto-reject system for both incorrect label data and missing label detection with reject verification
  • Touch screen HMI with run mode and set up mode (key switch access) facility
  • Counter package with full count reconciliation
  • End of web detection
  • Applicator belt cassette system with tool-less changeover

Options

  • Validation documentation and implementation package
  • Recipe system for up to 100 products
  • 3 level password access
  • Printout facility
  • Continuous label supply via the Easisplice 470 unit
  • Queue switch control
  • Vision Systems for OCV / OCR / barcode
  • Rotary infeed & outfeed tables
  • Left and Right hand option available

VERSA CAP – VERSATILE CAPPING MACHINE

This high-performance straight through capper is designed to handle a wide range of cap shapes and sizes. It is easy to run, easy to adjust and uses a minimum of components to provide versatile, high-quality capping. The Versa Cap is designed for rapid change over by using a minimum of capsize change parts. One sorter, chute, and adjustable chute end can handle most caps in either the 13-38mm or 38-70mm size range. A simple quick-change adjustable chute end that snaps into position without tools is needed for each major capsize variation.

Cushioned gripper belts are adjustable to move containers of nearly any size and shape smoothly through the capping operation without the need for timing stars or feed screws. Caps are positioned from a chute in the cap escapement assembly, picked up by the container neck finish and positioned for tightening. An independently driven overhead assembly with matching sets of polyurethane discs assures tight capping. The first set of discs gives caps a quick initial twist. The next set of discs draws the cap onto the container neck. The cap sorter, tightening discs, and machine/conveyor are controlled through three electronically controlled variable speed drives.

The Versa Cap is designed for rapid change over by using a minimum of capsizing change parts. One sorter, chute, and adjustable chute end can handle most caps in either the 13- 38mm or 38-70mm size range. A simple quick-change adjustable chute end that snaps into position without tools is needed for each major capsize variation.

The Versa Cap can be used as a mono-capper in conjunction with any high-speed Cozzoli rotary filler in a monoblock design. Combined drives and controls result in a compact, space-saving, cost-efficient filler/capper combination which is easy to operate, changeover and maintain. Snap capping, overcapping, and fitment inserting can also be readily accomplished on the versatile Versa Cap

For more information or to request pricing, please contact our corporate offices at 800-829-5741.

The Torqo 1600 Accessories

The Torqo 1600 is easy to use, easy to set up, easy to move and low maintenance! Tooling is available for any threaded closure – including child resistant caps – and this compact unit delivers and stores precise results at the touch of a button.

It now comes pre-equipped with Universal Torqo Chuck, As an increased variety of closure designs have gained prominence and popularity in the industry, Mesa Labs has developed a new Universal Chuck to accommodate multiple serration patterns and cap sizes with a single change part.

The torqo can be fitted with the all new Model 1506 Beverage Bottle Clamp is a quick-acting bottle holding device that can be easily adjusted to accommodate from 10 oz. to 3 liter bottle sizes.

The Model 1624 Quick Clamp Vise is an easy to use bottle holding fixture that combines the flexibility of a lead screw pin vise with the rapid loading and unloading of an over-center type clamp. This vise is capable of holding round bottles from 5/8-inch diameter to 6 inch diameter and square bottles from 5/8-inch to 6 inch. Short and long pins are available.

The 1626 Slide Chuck can be used to torque test roll-on-pilfer proof (ROPP) caps which are commonly used to package product in the alcoholic beverage and wine industries. The unique jaw sets allow the chuck to grip the rolled on serration patterns of the cap in order to perform both destructive and non-destructive torque testing.

The Yoke Chuck extends our testing capabilities beyond the average continuous thread and Child-Resistant closures. This chuck can accommodate unusually tall and odd-shaped closures such as finger tip sprayers/pumps and trigger sprayers/pumps which are commonly used in the pharmaceutical, chemical and cosmetic industries. The unique interchangeable jaw sets allow the chuck to grip virtually any serration patterns for cap diameters up to ~100mm.

With a 1507 Calibration Kit, the accuracy of your Torqo can be verified or a complete on-site calibration can be performed by the user. Contained in this kit is a precision Calibration Disk, a ball bearing load support assembly and the necessary hardware to use this kit. The weights required for performing a calibration are not included in the kit but may be purchased from Mesa Laboratories, Inc.

And one of the most demanded Torqo Accessories is the Child Resistant Closure Option.

The Model 1605 Child Resistant Closure Option enables the Torqo to be used for measuring the removal torque on the child-resistant type cap that requires a downforce in order to be opened. An air supply with the ability to provide a minimum of 60 PSI is required for this option. Both an air filter and an adjustable air regulator are contained in this kit and permanently mounted to the drive cover. The installation of this option on a Torqo does not affect in any way its use on conventional bottles and caps.

To find out more about the Torqo 1600 or the available accessories, please give us a call at 800-829-5741.

Bahnson Stability Chambers

Bahnson Environmental Specialties have developed a clever solution to meet your chamber volume and mobility needs.

The precise air control system ensures conditioned air to be distributed uniformly across your product shelves. A stainless steel impeller moves the air through the air conditioning components within the enclosed plenum. Air is then distributed and returned through the plenum’s side wall ports which are specifically arranged for maximum uniformity and efficient thermal transfer.

The conditioning system features:

  • Temperature control within +/- 0.2 C
  • Relative Humidity control to +/- 0.7% RH

All models in the ES2000 series provide precise control of temperature and humidity. The chambers feature full stainless steel liner conditioning system cover, and air walls. Solid, reinforced stainless steel shelves are easily removable and repositionable.

For more information, please give us a call.

Elevators and Lowerators

Vetromeccanica Elevator – Lowerator: The Optimal Solution for a Gentle Handling of Containers!

Many automated floor conveyor systems need to operate continuously on more than one floor of a warehouse or factory building. A means of raising or lowering product loads between different elevations of the conveyor system is therefore required, often within very restricted floor space. Elevators and lowerators are an efficient means of achieving this.

Contact Life Scientific today to discover more about our conveying capabilities.

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