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July 1, 2015
by Jessica Hamelburg
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Single-use vs Non Single-use Bioreactors

Single-use bioreactor technology is more than a decade old. In that short time, these single-use units have quickly become an established addition to today’s biotechnology manufacturing facility because of the great number of advantages these disposable bioreactors provide. While there many advantages to single-use bioprocessing technology, reusable bioreactors are still the technology of choice for many biotech producers.
 
Benefits of Single-use Bioreactors
bioreactor1Because it uses a disposable bag instead of a culture vessel, flexibility is one of the big advantages to using single-use bioreactors. Drug manufacturers are increasingly moving towards becoming multi-drug facilities, which must be able to produce several drugs within one facility at minimal time and cost without compromising the quality of each drug. The main bottleneck in such facilitiesis usually validation of cleaning and line clearance, which ensures no carryover from one batch to the next. Over time, this downtime results in fewer batches.
 
Reusable bioreactors require expensive and bulky clean-in-place (CIP) or steam-in-place (SIP) installations. The disposable bag of the single-use bioprocessors circumvents the need to use CIP and SIP systems. The disposable bags are usually made of a three-layer plastic foil, with the layers frequently consisting of polyethylene, PVA, PVC, and polypropylene combinations to minimize leakage.
 
Single-use bioreactors are suitable for cultivating human cells, insect cells and other cell types with relatively low oxygen demands, whereas reusable units have a wider scope of possible uses. While efficient and relatively versatile, there are some drawbacks to single-use bioreactors.
 
Reusable Bioreactors are Preferred in Some Situations
Scalability is an issue, in that large-scale operations need larger-scale bioreactor bags, which are not always readily available. Single-use units require repetitive purchases, which increases production cost. Fluctuations in the single-use bag market can cause an increase in the variable costs per run.
 
Single-use bioreactors are easy to move when empty but difficult to move when full; they also have non-advantageous increased pressure and temperature sensitivity. Furthermore, many single-use units have limited liquid transfer capabilities, making them inefficient in greater than 10,000L bioreactor scale processes. Most cannot store hot liquids. Others contain leachable compounds in the linings.
 
Reusable bioreactors are superior in some ways, especially for dedicated products. Most large-scale facilities have already invested in the ground, installed the tanks, and acquired the necessary cleaning validations to support multiple product use. Reusable bioreactors also present less potential for puncture. Furthermore, single-use units incur greater disposal costs than do reusable units.
 
Choosing between single-use and reusable bioreactors depends largely on the number of products offered by a facility, access to disposable bioprocessing supplies, room and cleaning costs.


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June 29, 2015
by Jessica Hamelburg
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Restricted Access Barrier Systems (RABS) or Isolators VS Cleanrooms

Are Restricted Access Barrier Systems (RABS) and isolators superior to traditional cleanrooms?
 
cleanroomIsolators emerged in the 1990s but fell short of expectations, leading to the development of RABS to serve as an alternative. Aseptic processing since has evolved into a diverse manufacturing technology with at least three major means of creating a sterile environment: aseptic clean rooms, Restricted Access Barrier System (RABS), and isolators. Despite the FDA’s assertion in their principle aseptic processing guidance document that isolators are superior in their ability to control contamination, there is a great deal of disagreement in the industry regarding the comparative effectiveness of each system.
 
All three have equal aseptic requirements. Many companies, especially large pharmaceutical companies, are switching from cleanrooms to isolators or RABS, but opponents of the trend say that RABS and isolators actually increase sepsis.
 
Weighing the Options
Isolators have regained some favor in the past few years, boosted by better technology and a reduced cleaning cycle. An isolator can serve as an alternative to a sophisticated cleanroom. Manufacturers generally use isolators in applications that require a great deal of protection from contaminants or external elements, as this equipment creates a nearly complete separation between a product and its production equipment, personnel, and surrounding environment. Isolators maintain a light, positive air pressure that prevents contaminants from entering through any openings while workers perform duties through glove isolators.
 
Isolators are preferable in processes requiring a built-in air filtration system that can significantly lower particle count in an enclosed area. Manufacturers working in small spaces appreciate the compact size of isolators and the ease of cleaning with gas or vaporizer sterilizing agents. An isolator has an automated bio-decontamination system that utilizes vaporized hydrogen peroxide, whereas cleaning RABS is a manual process.
 
RABS are in an open environment, where air flows freely out of the RABS to the surrounding room. People are the largest source of contamination in a cleanroom, so isolators and RABS serve as a physical barrier between people and the filling process.
 
Flexibility
RABS give workers more flexibility because they can open doors – one of the main problems with isolators is that the operator cannot access the process while it is running. There is an emerging trend of RABS units without glove isolators, as gloves can present more work, increased risk for contamination, and glove failures within the isolator system.
 
Costs
RABS and isolators tend to be more costly than traditional cleanroom. In many cases, RABS are a new type of equipment that employees must learn to maintain and operate correctly. Maintaining a cleanroom can be expensive, as well, when accounting for the costs of operating, energy, and testing that ensure the entire room is clean.
 
The costs for cleanrooms are well defined, but cleanroom installation can pose substantial expenses for engineering, ventilation, heat, and air conditioning. Compared with cleanrooms, RABS have higher equipment-related, operating, and overall costs. Isolators generally cost more to install and operate, and present additional costs for vaporized hydrogen peroxide and the time used for bio-decontamination, but RABS may present cost savings in gowns, supplies, and monitoring.
 
The time for qualification can take six to nine months for a barrier isolator, whereas qualifying cleanrooms is straightforward and quick.
 
The industry is undecided when it comes to choosing between cleanrooms, RABS, and isolators. Each manufacturer must weigh the benefits and disadvantages of each system.
 
 
Source: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070342.pdf, http://www.americanpharmaceuticalreview.com/Featured-Articles/36878-Clean-Rooms-RABS-and-Isolators-Validation-and-Monitoring-in-the-Diverse-World-of-Aseptic-Processing/


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June 22, 2015
by Ashley Parrelli
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Manufacturing Solutions Using Heat Exchangers

Manufacturing facilities face a variety of energy management challenges while controlling their processes and environmental conditions. Chemical manufacturers require large amounts of heat to carry out reactions, distillations and crystallization. Additionally, heat must be dissipated to control reactions. Similar processing of hydrocarbon liquids takes place in the oil and gas industry. Pasteurization, concentration, freezing and other food and beverage production methods involve substantial heat transfer as well. The automotive and aerospace industries commonly employ radiators, evaporators and condensers. These mechanisms are examples of heat exchangers. Heat exchangers are devices that transfer heat from one medium to another, usually without mixing. There are several types of heat exchangers available. When choosing a heat exchanger, a thorough evaluation should be conducted to ensure optimal performance.

 

Shell and Tube Heat Exchangers

 

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Shell and Tube Heat Exchanger

Shell and tube heat exchangers are constructed with two sets of tubes through which fluid flows. One set carries the fluid that will be heated or cooled while the other set conveys the fluid that will conduct the heat exchange. Shell and tube heat exchangers may include many design variations. Tube diameter, thickness, length and pitch may affect efficiency and performance. Their durability lends to their use in high-pressure applications.

 

Plate Heat Exchangers

 

Plate heat exchangers are comprised of several thin, narrowly spaced plates. Small channels allow fluid to flow between the plates to accomplish heat transfer. Plate heat exchangers may vary in plate type or configuration. In plate and frame heat exchangers, plates are typically separated by gaskets and may be disassembled for cleaning. This type of heat exchanger is often employed in open loop applications such as HVAC. Others have plates that are permanently welded or brazed and are most frequently used for closed loop systems such as refrigeration.

 

Adiabatic Wheel Heat Exchangers

 

Adiabatic wheel heat exchangers use an intermediate liquid to retain heat. This liquid is transferred to the other side of the mechanism where heat exchange takes place. These heat exchangers are comprised of a wheel with filaments that are rotated through hot and cold liquids to facilitate the transfer of heat. They can be used for heating or cooling applications and are commonly employed in petroleum refining and pasteurization in the food industry.

 

Spiral Heat Exchangers

 

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Spiral Heat Exchanger

Spiral heat exchangers have two flat surfaces configured to form spiral channels. The flow of liquid through the channels is in opposite directions and can be one of three types: counter current flow, spiral/cross flow or distributed vapor/cross flow. The curvature of the channels provides highly efficient heat transfer. Their unique shape and characteristics allow them to be used in a number of applications including heat recovery, effluent cooling, pulp and paper processing and sludge treatment.

 

Solutions for Manufacturing

 

Heat exchangers have numerous industrial applications. They are widely used in manufacturing processes such as condensation, pasteurization and distillation. Heat exchangers can also provide energy savings that reduce operating costs. They recover heat that is produced as a by-product of processing and convert it into a usable energy form to be used elsewhere. This significantly reduces waste and saves energy required to carry out other processes.

 

Conclusion

 

Heat exchangers are available in a variety of types and configurations and may be customized to meet application requirements. A thorough understanding of the process is necessary to determine the type of heat exchanger needed for optimal performance. Heat exchangers provide an effective means of improving efficiency and lowering operating costs.


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June 18, 2015
by Jessica Hamelburg
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Day 3 Update at Pack Expo Mexico City!

We’re onto day 3 at Pack Expo in Mexico City! The last few days were nice and busy with a lot of traffic, and we were able to meet a lot of new people. It’s great connecting with others in the field.

packexpo1

We’ve also had the opportunity to check out some cool exhibits and presentations. We’ve met loads of great potential clients, and we still have one more day at the show. If you have not seen us here yet, we can be found at Booth #3604 – make sure you come say hello! We are looking forward to a successful final day tomorrow at Pack Expo for all!


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June 15, 2015
by Sarah Kilburne
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3 COUNTRIES, 3 TRADESHOWS THIS WEEK!

 
EquipNet will be across the globe this week exhibiting at 3 different tradeshows!
 


 

achema

ACHEMA – GERMANY

We have team members from our Chemical, Pharma and R&D groups and representatives from our UK office in Frankfurt, Germany at ACHEMA 2015! They will be at Booth 3.1E98 all week so if you’re visiting Germany for the trade show, make sure to stop in and say hello!
 


 

biointernational

BIO INTERNATIONAL – USA

We also have team members in Philadelphia, Pennsylvania exhibiting at the BIO International Convention! Planning on walking the show? Talk to our Bioprocessing specialists at Booth #3426 to learn more about our Asset Management programs and the available surplus we have for sale.
 


 

packexpomex

EXPO PACK – MEXICO

You’ll find our LATAM team at Expo Pack Mexico from Tuesday until Friday! If you’re planning on being at this show, swing by and say hello at Booth #3604. Our team members would be happy to speak with you about all our current project in Latin America and relevant equipment across the globe!
 


 


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