Softgel Manufacturing

softgel-manufacturing

Introduction

Leads the industry in innovation
•World class products
•Broad and deep experience
•From a single machine to a complete manufacturing and packaging facility
•Pharmaceutical, nutraceutical, cosmetic and paintball industries

We understand softgels – from formulation through packaging.
We can help with your formulations, determine the best equipment for
your needs , and design your entire facility. Our understanding of
softgels goes well beyond manufacturing equipment. We understand the day to day challenges of running a plant at peak efficiency. We use that
knowledge and our customer’s feedback to build the best softgel
manufacturing equipment available.

Saintyco-R2 Encapsulation Machine

Plant Layout and Design

The following plant requirements interact one with another and need to be carefully evaluated:

•Climate control
•Facility constraints
•Formulation development

•Machine costs (both capital and operating)
•Product handling and packaging needs
•Production objectives

SaintyCo Technologies couples its extensive experience in
plant and equipment design with it’s knowledge of day to day
operations of softgel manufacturing. These parallel
experiences make us uniquely qualified to assist in the
design of your facility.

saintyco-R-2 softgel

Temperature and Humidity Control

Controlling temperature and humidity are vital to a successful softgel manufacturing operation.
Questions to consider include:
•What are the required conditions for manufacture?
•What are the dimensions of the area to be conditioned?
•Will there be an internal heat load and if so, how much and where is it?
•How much humidity is allowed in the specialized areas?
•How will humidity be increased or decreased by the process and
equipment in the facility?
•Are there special environmental requirements?
•How might the climate of location affect the facility? Altitude, seasons?
•How are the requirements altered with additional shifts?

We can guide you through the process of optimizing your
environmental and operating plans. Or, we can also do it for you
with a turnkey solution.

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Product Development

SaintyCo Technologies understands product development. We can help
you save time and money often associated with product development.

Our team has expertise in a wide range of softgel formulations,
including: oils, gels, suspensions, emulsions and pastes.
We will help you develop an efficient, scalable, transferable
process that optimizes your product’s stability and bioavailability
characteristics.

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Process Documentation

The quality of your product will be directly affected by the
quality of your process documentation. Our IQ, OQ, and PQ,
validation processes help you assess, develop and
implement the appropriate processes to meet your
quality and regulatory requirements.

We can provide you with any of the following documentation:

• FAT – Factory Authorize Test
• IQ – Installation Qualification
• OQ – Operational Qualification

The Five Steps of Softgel Manufacturing

Gelatin Preparation – the process of blending and heating granulated gelatin and other
ingredients in warm water in a gelatin melting tank. With appropriate heat, mixing
and vacuum, the ingredients form a thick syrup called a “gel mass” for use in encapsulation.
Color may be added during the melting process or in a separate machine.

Fill Material Preparation – the process of preparing the non-aqueous oil or paste that will be encapsulated.
Preparation equipment may include: processing tanks, mixers, vacuum homogenizers, sieves and mills. Heated and
unheated transfer tanks may be used for the fill material and gelatin while waiting for encapsulation.

Encapsulation – the process of converting the gel mass into a thin layer of gelatin and wrapping it around
the fill material to form a softgel. Click here to see how an encapsulation machine works.

Drying – the process which removes excess moisture from the gelatin shell to shrink and firm up the softgel. Drying
occurs either by tumbling or by a combination of tumbling and tray drying.

Cleaning, Inspection and Sorting – often required prior to packaging based upon the intended use of the softgel.

Installation and Training

Our installation and training are custom tailored to fit your needs.
We can:
•Completely install your equipment
•Customize training to specific needs of your employees
•Offer full spare part support
•Conduct real time ethernet troubleshooting

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Innovations

SaintyCo Technologies has pioneered many innovations in softgel production. Below are some examples
of our continued efforts to advance the capabilities of our softgel equipment:

Innovation Increases
Production
Improves
Quality
Reduces
Operator
Involvement
Speeds
Product
Changeover
Automatic Ribbon Control
• Automatically controls gel ribbon thickness
• Reduces gelatin loss and set up time by 84%
• Extends die roll life

Automated Gel Feeder

• Ensures consistent gelatin supply

Independent Clutched Fill Material Pump Drive
• Allows fill pump to be stopped and started without affecting gel flow or machine timing
Radically Improved Wedge Design
• More effective softgel sealing at higher speeds
• Superior heat control
Improved Spreader Box
• Superior heat control
• Swing out feature
• Lightweight
Improved Cooling System
• Never requires additional water
• Superior cooling
• Internal design
Simplified Timing Verification
• Requires only one person
• Independently lit and magnified
 
Remote Troubleshooting Via Internet
• Capable of online connection to CapPlus technicians
   
Continuous Tumble Drying
• High velocity blowers
• Extra large baskets

Automatic Softgel Polisher

• Feeds softgels directly from dryers
• Fast enough to keep up with any encapsulation machine
• Continuous and intermittent flow controls
• Electronic timers capable of multiple settings

 
Gelatin Preparation Equipment

Gelatin Melting Tanks
• 50 to 2,000 liters
• Stationary or Portable

gelatin-preparation-equipment-gelatin-melting-tanks  SAINTYCO-PDF

Color Mixer
• For coloring gelatin
• Wall mounted or floor standing

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Gelatin Transfer Tanks
• 50 to 300 Liters
• Floor level feeding
• Mobile

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Fill Material Preparation Equipment

Colloid Mill
• Used for particle size reduction
• Passes material through grinding stone
• Useful for pastes or suspensions

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Vacuum Homogenizer
• Blends fill material
• Uses vacuum to remove air
• Can be wall mounted for ease of use and saving space

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Fill Material Transfer Tank
• 50 to 300 liters
• Water jacketed for heating
• Floor level feeding
• Mobile

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Our Encapsulation Machines
The R Series Output/Hr

R&D-3 Softgel Machine

• Operating speed of up to 3.5 RPM
• 2″ x 6″ die rolls

# 2   Oval 31,920
# 5 Oval 17,850
# 7.5 Oval 14,280
# 12 Oval 12,600
# 12 Oblong 11,340
# 15 Oblong 10,080
# 17 Oblong 9,450
# 20 Oblong 9,450
# 22 Oblong 9,450
# 5 Round 20,580
# 10 Round 15,120
# 40 Round 10,500
The R Series Output/Hr
R-2 Softgel Encapsulation Machine
• Operating speed of up to 5 RPM
• 10″ x 6″ die rolls
#8 Oblong 100,800
#10 Oblong 98,400
#16 Oblong 84,000
#20 Oblong 58,800
#6 Oval 140,400
#8 Oval 120,960
#10 Oval 106,080
#14 Oval 92,160
#16 Oval 81,840
#30 Oval 93,960
#40 Oval 74,520
Drying

Drying occurs by tumbling or by a combination of tumbling and tray drying
Standard Tumble Drying
• 1 to 6 baskets
• Drying trays in tunnels
Continuous Tumble Drying
• 8 to 16 baskets
• Larger baskets and blowers
• No trays or tunnel
Tray Drying – The softgels come out of the tumble dryers and are placed on paper lined drying trays. The trays are then stacked on dolleys and pushed into drying tunnels. This method is used in a multiple product process.
Continuous Drying – Continuous drying uses more and larger tumble dryers, the softgels spend more time in the dryers. This method is usually found in a single product process.

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Cleaning and Inspection & Sorting

PharmaSpec – Semi-automatic inspection machine
• Variable flipping, vibrator and rolling speeds for efficient inspection

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Thick-Sort – Fully automatic diameter sorter
• up to 400,000 softgels per hour
• Fully adjustable for different sizes

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Softgel Polisher – Removes oil and shines softgels
• Up to 500,000 softgels per hour
• In-line – add it to the end of dryer line

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Softgel Pulverizer – Separates and recovers fill material
from defective softgels
• Up to 200,000 softgels per hour

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Softgel Tooling

Die Rolls
• Die rolls are available in a variety of sizes and cavities
• Made from hardened anodized aluminum
• Space between pockets is “bead blasted” to minimize gel adhesion
• Easier to time with colored timing marks on front of die rolls

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Wedges
• Faster heat transfer from the Teflon® coated aluminum wedges to the gel ribbon
• Available in a variety of sizes depending upon which system you are using

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Timing Gear
  • An integeral part of the softgel kit

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Distribution Plate
• “Gasket Free” Teflon® distribution plate improves regulatory compliance

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