What if vaccines get too warm?

In healthcare, helping secure patient safety is crucial. That’s why health care providers work tirelessly to ensure their actions support this mission. Though despite their best efforts, mistakes happen, and unfortunately, vaccine storage solutions aren’t often up to standards. For instance, in October 2017, a healthcare agency in California made an accidental, but unfortunate overcorrection. Due to concerns that their vaccines were too warm while in transport, they utilized ice packs to cool them down. Later, a routine audit found that some vaccines became too cold and froze during the drive.

Because they couldn’t say for sure which vaccines maintained the integrity and which ones didn’t, everyone who received their vaccines required reimmunizations.

In the end, this mistake affected 23,000 patients.

As mistrust in vaccine integrity grows, there is no room for error. Nevertheless, there are steps healthcare providers can take to avoid the worst and stay prepared.

We’ve recently published an article covering the importance of having a dependable vaccine storage installed on site, but today we shift our attention to controlling and monitoring equipment for the complete cold supply chain.

Not Too Hot, Not Too Cold: Maintaining the Perfect Temperature Range

Preparing for the what-ifs is an essential part of working in healthcare environments. First things first, always read the packet insert provided by your distributor. This insert will guide you to the right storage temperature for your vaccine.

For more guidance, here’s what The Centers for Disease Control and Prevention (CDC) suggests for ideal temperature ranges:

  • Refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F).
  • Freezers should maintain temperatures between -50° C and -15° C (-58° F and +5° F). Refrigerator or freezer thermostats should be set at the factory-set or midpoint temperature, which will decrease the likelihood of temperature excursions.

Another element that affects the temperature of your vaccine is the placement. For instance, avoid storing vaccines in refrigerator doors as opening and closing the doors makes vaccines vulnerable to warmer temperatures. In fact, the CDC recommends storing your vaccines in the middle of the fridge and placing older assets towards the front, so utilization happens before they expire.

All in all, proper monitoring is crucial to ensure that your assets maintain integrity.

The truth is, it takes a village and then some. Following guidelines that support successful audits and healthy patients is critical. That’s why manually monitoring the temperature of your storage units is not always the best solution. Having a continuous temperature monitoring system in place that not only alerts you when your temperature goes awry but also keeps accurate records of every temperature your units are experiencing is essential.

When you have an action plan, you worry less. If you want better certainty that the vaccines you’re giving patients are potent, you need a temperature monitoring system in place that sends you alerts and notifications when something goes wrong.

Many monitoring systems come equipped with an alert function. Some facilities prefer to use continuous monitoring systems that utilize the phone tree method. This method sends notifications to one member of the team when their designated parameters drop below requirements making them the first line of defense. If the first member of the team is unable to go on-site to address the problem, they can choose to pass the alert to the next person on the list.

Having a system in place that has thorough reporting for audits is non-negotiable. These reviews verify that you’re doing everything in your power to provide excellent patient care, and your reporting system will prove this. In turn, an adequate reporting system saves your team time and ensures that your paperwork will be in order when governing bodies like the FDA or Joint Commission come knocking.

Having proper notifications allows you to address the problem immediately, wasting no time.

For example, with Mesa’s ViewPoint Temperature Monitoring System alerts users of any readings that are outside the programmed acceptable range for that appliance undergoing monitoring. The ViewPoint monitoring system emails and sends text notifications of an alarm state to users’ day or night. Multiple email addresses, cell phone numbers, and alarm notification lists can be utilized, providing the client with the best line of defense against any issue regarding your valuable products.

With ViewPoint, healthcare workers maintain full transparency with their assets and that security is priceless.

Priority: Potent Vaccines

Achieving Effective Assets with Continuous Monitoring

When it comes to safeguarding your valuable assets, your monitoring tools should be the best. Healthcare environments are complex, and when data is funneling in from multiple inputs, or hand recording is utilized, the complication amplifies. That’s why it’s crucial to create a system that gives you reliable and usable data along with accurate reports that meet regulatory requirements.

Ensuring drugs remain valid, and blood samples maintain viability is critical to mitigating product loss and health risks. To do so, you will need an efficient, flexible continuous monitoring system that upholds all regulatory requirements.

If you want to have a further conversation on how we can help out with your vaccine storage needs, please get in touch with us via 800-829-5741.

STERILITY TEST ISOLATOR with Built-in Hydrogen Peroxide Vaporizer

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:

  • Injectable liquids.
  • Ophthalmic ointments.
  • Sterile antibiotic powders.
  • Freeze-dried drugs.

When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.

FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.

This innovative design provides real time biocide concentration control (over traditional estimated calculations).

Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence.

The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.

DESIGN & TECHNICAL FEATURES

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
  • Air-tightness is 100% guaranteed by ultra-safe doors.
  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
  • Customizable internal storage and racks: can be designed according to customers’ needs.
  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.

KEY BENEFITS

  • Significantly reduced operational costs: Non-proprietary consumables.
  • Reliability: Leak testing totally managed by Thema4.
  • Easy integration, throught Thema4, with other Fedegari machines and SCADA systems.
  • Cost-effectiveness: Drastically reduced validation time for cycle and load.
  • 100% air tightness: Silicon inflatable patented gasket on all doors.
  • Process control based on direct feedback, instead of estimations.
  • Grids and internal spaces that can be customized according to the load.
  • RTP Port for loading and unloading activities.

COMPLIANT TO

  • European directives: 2014/30/EU – electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
  • European standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
  • FDA: compliance for non metallic component in contact with process fluids
  • GMP
  • GAMP5
  • 21 CFR Part 210, 211 e 11
  • UL 508A
  • NFPA-79
  • ASME BPE

Optional

  • US electrical norms: NFPA 70 – National electrical code,  UL 61010-1 – Safety requirement for electrical equipment for measurement, control and laboratory use – Part 1: general requirements.

Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.

LF of America Dual Chamber Bottles

Need to mix two different products just before application? LF of America Dual Chamber bottle with reservoir is your answer.

This dual-chamber bottle allows for liquid + powder products to be placed in the same container. This unique container also features a tamper-evident cap.

Here is how it works: the 10 mL bottle and 1.5 mL reservoir provide separate storage of two different products.

Applying pressure on the top of the cap, the internal membrane is perforated and allows the contents of the reservoir to flow into the bottle. The two products can now be mixed together right before use.

Contact us today with any questions you might have.

Mario Negri Institute FOWS Case Study

The Challenge

Design and deliver a complete cost-effective solution for washing and sterilizing animal cages with full backup of all process equipment. Use the equipment process chambers as chemical decontamination pass-through.

Project requirements:

Washing and sterilization of:

– 3.000 animal cages (metabolic and green line) of different sizes and relevant accessories per week

– Cage lids and grids, once/twice per month

– Animal food packages, as needed

– Sawdust packages, as needed

– Feeders, as needed

Chemical decontamination of:

– Various heat-sensitive instruments and items Max cycle time: 100 min

The Customer

Mario Negri Institute for pharmacological research is a not-forprofit biomedical research organization structured on four research centers in Italy (Milan, Bergamo, Ranica and Chieti), a foundation in the US and employs about 1.000 personnel, mostly researchers. The main fields of activity are the battle against cancer, nervous and mental illnesses, cardiovascular and renal diseases, rare diseases and the toxic effects of environmental contaminants, mother and child health. Mario Negri Institute and Fedegari have been collaborating for decades and in 2007 Fedegari has been awarded the contract for supplying two FOWS washer sterilizers for the new research facility in Bergamo.

The Solution

Installation of two FOWS washer sterilizers side-by-side capable of washing, sterilizing and drying various types of animal cages in one single process. The machines are equipped with different rotating and static spray nozzles located on the sterilization chamber walls as well as on the racks, so as to cover all load surfaces. No manual operation is needed to connect the rack to any water feeding system; a simple maintenance-free auto coupling ensures the water flow through the rack. The same device also allows feeding steam through all the nozzles for improving cleaning performances in a way no traditional washer can do.

Cycle duration is approximately 100 min, considering 20 min for the wash/rinse phase and 20 min for sterilization. The water consumption for this application is approximately 250l each process. Like a typical steam sterilizer, drying is performed with a vacuum after sterilization, thus avoiding the use of HEPA filters.

Due to the specific requirements, both machines are equipped with a vaporized H2O2 generator for decontaminating those heat-sensitive items that need to be transferred inside the animal holding room. With this solution, it has been further reduced the number of machines installed and the relevant acquisition and operating costs.

LF of America Your Partner In Contract Filling Florida

If you are in need of contract filling services in Florida, you’ll want to know you can depend on the company you choose. When it comes to the contract packaging and filling industry, little more is as important as reliability. 
Any business that can’t rely on their contract filling services, its reputation is what gets hurt the worst. Proper protocols, handling, and a commitment to following any regulatory practices are all just as important. 

An error to follow these vital standards could amount to your product becoming tainted or less effective than it is meant to be. Similarly, a disruption in ongoing fulfillment can slow your own production and leave your business with significant problems to overcome.

These factors stand true for almost all imaginable industries. Whether OTC products, diagnostics, health and beauty, or something else entirely, contract filling plays a highly important ongoing role.
Fortunately, for anyone looking for an experienced and reliable Florida contract filling and packaging company, our experts can help. 

Contact LF of America today to speak with a member of our team and learn more about what makes us the premier choice in contract filling services below.

Your Source For Reliable Contract Filling Services In Florida

LF of America is the leading provider of contract filling services and liquid packaging solutions in the US. Our experienced team understands that every time a client entrusts us with their products, we become a vital part of the company’s chain.

For this reason, we put a strong emphasis on safety and compliance during each phase of the production process. It’s important to us that each and every one of our clients knows they can depend on our contract filling services to be done in a safe, effective manner.

To achieve this, we handle all of our services in contained settings with our state of the art facility. Our semi-automatic and automatic filling and sealing machines are some of the most highly advanced available, equally capable of handling small batch orders to large full-scale production sizes.
The filling and sealing machines are stationed inside our ISO-8 clean room. The ISO-8 cleanroom is immaculately maintained to remain in total compliance with Cosmetic GMP regulations, an extension of the Quality System Requirements for medical devices.

Contract Packaging Options

For packaging options, our contract filling services can be performed using your own existing containers or you can choose from our diverse variety of packaging types. Our collection of innovative packaging options include unit-dose packaging, Bellow Bottles, wand tubes, enema containers, bottles with droppers, dual chamber bottles, and more.
All of the different types of options available through our packaging manufacturing department are suitable for many different applications. Please fill out an inquiry form to request our help with developing a unique packaging solution that is ideal for your intended purposes.

If you would like to receive a free estimate regarding the cost of our Florida contract filling services, call LF of America at 561-988-0303.

Moving forward, consider the entire LF team your ideal packaging partner to help your business continue to grow and achieve the goals you set out to conquer.

Vetromeccanica AirTech

Vetromeccanica recently introduced their brand new AirTech system.

The AirTech is an Air Conveyors Solution extremely efficient for Empty Containers.

AirTech enables production chains to move empty containers evenly in case of high inclination (slope of max. 15° according to the bottle shape). This conveying solution allows Maximum flexibility, manageability and fast format change where a switch of containers is done in a single line. One of the best features of the new AirTech system are the redesigned body guides that provide customers with an automatic adjustment system included in their conveyor.

AirTech belongs to the Air conveying solution, which are conveyors that use air to move products and materials rather than mechanical belts or chains. Air conveyors are most widely used to move lightweight objects such as empty containers, boxes, and trays at speeds often exceeding 1,000 fpm. However, AirTech can be configured not to be limited to lightweight materials.

To learn more about Vetromeccanica’s AirTech, feel free to connect with our representatives.

Cozzoli Ampoule Filling Machines

Our full line of Cozzoli ampoule filling and sealing machines accommodate a range of products from aqueous solutions to powders and even pellet applications. These high-speed ampoule filling and sealing machines are versatile, compact, and self-contained. These features, along with the accessibility of parts and minimal changeover time contribute to the successful operation of these machines.

The FPS – Ampoule Filling and Sealing machine is ideal for filling and sealing ampoules with speeds from 15-120 ampoules per minute and a fill accuracy of +/- .5%. The FPS is designed with a sealed top cover plate to ensure the internal drive mechanism remains free of extraneous matter.

The FPS series is a compact ampoule filling and sealing monoblock machine; featuring an unscrambler, flushing and filling stations and is known for it’s simplicity, operational reliability and minimal maintenance factors. Utilizing Cozzoli’s exclusively patented sliding tube valve, the FPS uses stainless steel syringes and positive head pressure to fill the product with outer diameter dimensions up to 1” (25.4mm) at full speed. Ampoules from 25.4mm to 28.6mm can be handled by alternate indexing.

Fill volume can be changed by a simple adjustment of a calibrated sector arm. Volumetric accuracy of fill is +/- 0.5%. Bottom-up filling is provided through the provision of two cams to lower and raise on a 2” or 5” stroke. Other cams are available for any special bottom up filling requirements.

Since the blending of proper amounts of oxygen and gas is important for effective sealing of the ampule, this machine can be optionally equipped with a dual flow meter assembly that will visually indicate the oxygen and gas flow separately.

Interested in discussing your ampoule filling needs, contact us today.

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.

Understanding the challenges and solutions for manufacturers of metal cans

The Metal Cans category of packaging was invented in the beginning of the nineteenth century and has been used for more than 100 years. With time, its scale of use expanded into a variety of end-use commodity packing purposes such as food & beverage items, chemicals, oil etc.

 Over the years, many improvements have been made to the design: materials used for the cans such as aluminum, steel, tin and internal/external protective organic coatings; manufacturing equipment for 2 and 3 piece cans; chemical process monitoring; applications like food & beverage, edible oil, pharmaceutical industry, personal care, and cosmetic products, industrial chemicals; and, quality control methods/instrumentation.

Today, due to the relentlessly growing global demand and production of millions of cans per day around the world, manufacturers are faced with the challenge of increasing production efficiencies to provide cost-efficient and scalable solutions. This means higher production speeds resulting in a higher number of units being produced per minute and huge numbers being transported worldwide. The manifold manufacturing process in the canning industry makes the entire metal can production complex and can involve quite a few machines from splitting to seaming.

The can manufacturing plants and their raw material suppliers are responsible for product integrity even before the distribution of the cans to the product manufacturers. Therefore, outgoing complete quality control of produced empty cans is an extensive practice at manufacturing locations. This control provides the possibility of eliminating package issues before they reach the filling process through scrupulous quality control procedures.

The quality testing of empty cans by manufacturers and of filled and finished cans help to act proactively by eliminating production challenges like:

→ Downtime during the filling process, leaks, and spillage.

→ Lengthy production time: formerly tested packaging will help save time during the production process.

→ Contamination and unsafe-to-use products leading to a product recall.

Hence, both empty can package testing and filled can quality testing is an appropriate choice for manufacturers. This will help to offer safe and sterile products contained within the metal cans.

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.
2 visitors online now
2 guests, 0 members
Max visitors today: 7 at 08:12 am
This month: 32 at 08-09-2020 02:04 am
This year: 112 at 05-24-2020 05:06 pm
All time: 253 at 10-02-2019 01:57 am