Empty Capsule

Empty Capsule

Empty hard capsules have been PharmaCapsulas’s key product from the company’s foundation.

For over 20years,PharmaCapsulas has been providing quality capsules to the customers all over the world. PharmaCapsulas has a DMF(Drug Master File)filed with the United States Food and Drug Administration, and the manufacturing facilities are cGMP(current Good Manufacturing Practices) compliant. Many multinational pharmaceutical companies have audited PharmaCapsulas’s manufacturing facilities. Currently, PharmaCapsulas are sold worldwide in more than 20 countries in five continents.

THE ADVANTAGE

  • Suitable for high speed filling machines
  • Superior stability for long term storage
  • Minimized deviation in length, weight, and moisture content
  • Capsules free of foreign matter and preservatives
  • Various printing options(Axial, Radial, Spin, Two-Color)
  • Precise color matching

Empty Capsule: The Ultimate FAQ Guide

1. What are Empty Capsules?

These are capsules that do not contain any form of products.

They are mainly hard gelatin capsules or two-piece capsules.

Empty capsules

Empty capsules

2. Are there Empty Softgel Capsules?

No.

The manufacturing process of Softgel capsules is quite different from the hard gelatin capsules.

That is, as the die rolls, gelatin ribbon moves while material fills to form Softgel capsules.

As a result, it produces hermetically sealed capsules.

Due to the hermetically sealed structure, it is virtually impossible and uneconomical to have empty Softgel capsules.

 Softgel capsules

Softgel capsules

3. Can you Buy Empty Capsules?

Absolutely.

There are quite a number of manufacturers who make empty capsules, which you can use to fill your powders, vitamin supplements or any other products.

In fact, filling your own capsule guarantees significant cost savings.

All you need is a reliable capsule filler machine.

4. How do you Fill Empty Capsules?

The process of filling empty capsules is virtually the same.

However, the stages will depend on the type of capsule filling machine you will be using.

Broadly, we have:

  • Manual capsule filler machine
  • Semi-automatic capsule filler machine
  • Fully automatic capsule filler machine

Whichever capsule filler machine you opt for, you will consider the following processes:

· Filling Empty Capsules with Manual Capsule Filler

When you are usingthe manual capsule filler machinethe processes involved include the following:

Manual capsule filler machine

Manual capsule filler machine

i. Prepare powder formulation or material you want to fill in the capsules

ii. You should lock and separate the capsules.

The process will involve placing capsules in holes of capsule filling machine, holding them at the right angle and position, locking capsules, then use the handle for the separation.

iii. Ensure the capsule body is on the same level as that of the filling surface of capsule filling machine

iv. Sprinkle or pour powder on the filling surface and tap gently.

Ensure the powder fills every capsule.

v. Remove the excess powder from the filling surface

vi. Return the tray with capsule caps.

Press it gently to cover the capsules that have been filled with material

vii. Remove the capsules from the manual capsule filling machine

viii. Inspect capsules if they meet the recommended quality standards and requirements.

Note: This the process of using manual capsule filling machine may vary slightly.

It will depend on the design and configurations of manual capsule filling machine.

· Filling Empty Capsules using Semi-automatic Capsule Filler

Semi-automatic capsule filler machinecomes with some degree of automation.

However, there are other procedures that you will handle manually.

The process of filling empty capsules using semi-automatic capsule filler involves:

i. Load the semi-automatic capsule filler with both capsules and the material you intend to fill.

The capsule filler has separate hoppers for both empty capsules and material.

ii. On a rotating disc, the capsule filler machine automatically feeds empty capsules into their respective holes.

It aligns capsules ready for filling.

iii. Separate the body from the caps by lifting the upper section of the rotating disc.

You will do this manually.

It is an aspect that makes it a semi-automatic filling machine.

iv. Fill the empty capsule body with a suitable material.

The machine will automatically pour the recommended powder quantity as the disc rotates continuously.

Unlike the manual capsule filler, the semi-automatic capsule filling machine is more accurate and controls the filling process.

v. Once the filling rotating disc returns to the original position, it is now time to cover the capsules.

vi. Return the upper section of the rotating disc in position, place the two back to the semi-automatic capsule filler.

vii. Semi-automatic capsule filling machines will automatically replace caps in the body; thereby forming completely sealed capsules.

Most capsule fillers have a compression zone.

viii. Fully sealed capsules will then move to the discharge chute.

From this point, you can subject the capsules to various quality tests and inspection.

· Filling Empty Capsules using Fully Automatic Capsule Filler Machine

A fully automatic capsule filler machine is accurate and faster than both the manual capsule filler and semi-automatic capsule filling machine.

Fully automatic capsule filling machine

Fully automatic capsule filling machine

Fully automatic capsule filling machines are suitable for high capacity or large scale production.

However, when it comes to filling empty capsules using fully automatic machines, you can choose from dosator capsule filler or tamping pin capsule filler.

· Filling Empty Capsules using Tamping Pin Capsule Filler

How a tamping pin capsule filler equipment works is also simple and straightforward.

It involves the following processes:

Tamping capsule filling machine

Tamping capsule filling machine

i. The process begins by loading both material and capsules in the capsule filler machine.

ii. Tamping pin capsule filler automatically orients capsules ready for the filling process.

iii. Empty capsule moves from the hopper via a vacuum system

iv. With the help of the vacuum system, it separates capsules ready for the filling process

v. As the dosing disc rotates continuously in a circular manner, powder from the hopper flows into the holes in the filling station.

vi. Tamping pins compress material (powder) in different stages.

As a result, they compact material, thereby creating more space.

vii. Dosing disc will rotate to the next stage for compression process, and the second tamping pin compresses the material.

viii. The compression process will continue until it reaches the last tamping pin (most automatic capsule fillers have 5 stages).

ix. It will scrap the compressed material to remove excess powder.

This ensures accurate, smooth and consistent capsule filling process.

x. At the last stage, a fully compacted powder will leave the dosing disc plate and eject it into the empty capsule.

xi. Rotating turret will move the filled capsules to the capping stage.

At this stage, it will cover the capsules, which ensures the excess material moves back to the material hopper.

xii. It will eject capsules to the discharge chute where you can take capsules for inspection, printing or other processing.

Remember, the tamping pin principle is fast and common in large scale capsule production.

· Filling Empty Capsules using Dosator Capsule Filler

For low weight fill capsules, you need a dosator capsule filling machine.

Again, the working principle of dosator capsule fillers is straightforward:

 Dosator capsule filler

Dosator capsule filler

i. Place both material and empty capsules in their respective hoppers.

ii. The dosator tip of the machine moves to the powder bed.

It exerts a force that forces the powder to fill the cavity which is just at the tip of the tooling system.

The size of this cavity will depend on the empty capsule size and dosator plunger.

iii. With the material in the dosator cavity plunger, it will exert more compressive force.

During this stage, it creates more space for filling powder and achieving a compacted powder.

iv. As the plunger leaves the material bed, it locks the powder

v. It will then trip the powder; a process also known as doctoring stage.

The process removes the excess powder.

vi. Dosator capsule filler will then open the empty capsules by removing the cap.

It uses a vacuum system to separate the capsules.

vii. Dosator pins will rotate to change position – That is, the tip with powder will move to the exact position of empty capsules.

viii. Pin with powder will move directly above the empty capsule where it discharges the powder.

ix. As the tip empties compressed powder into the empty capsule, the other tip dips in material bed.

This results in a continuous process.

x. Capsule filler will automatically close the filled capsules during a continuous rotary motion of the turret.

5. How many Sizes of Empty Capsules are there? And how much can Empty Capsules hold?

The amount of content an empty capsule can hold will depend on the overall length or dimensions of the capsule.

Therefore, you should evaluate the dimensions of empty capsules when they are joined and separated.

Take a look at this:

Capsules dimensions

Capsules dimensions

Now, depending on the dimensions of the empty capsules, they can hold products of different weights.

Again, when evaluating the empty capsules sizes, it is important to focus on the following key aspects:

  • Dimensions – this may include diameter, length after joining capsules, etc.
  • Weight
  • Volume

Some of the available sizes of capsules include 000, 00, 0, 1, 2, 3, 4, and 5.

The table below gives an insight on other specifications of capsule sizes:

Capsules sizes

Capsules sizes

6. What is the Difference between Vegetable Empty Capsules and Gelatin Empty Capsules?

Gelatin capsules vs vegetable capsules

Gelatin capsules vs. vegetable capsules

Broadly, the difference between gelatin capsules and vegetable capsules depend on the specific manufacturing ingredients.

Here is a detailed comparison between the two:

Gelatin Empty CapsulesVegetable Empty Capsules
They are made from animal products such as collagen. Therefore, they are suitable for consumers who can use animal productsVegetable capsules are made from cellulose or other plant products. Therefore, they are suitable for vegan consumers
Suitable for most powdered formulationsSuitable for semi-solid and gel formulations
Less expensive compared to the vegetable capsulesThey are more expensive compared to the gelatin capsules

7. Why should you Fill Your Empty Capsules?

Whether you want to fill powder, pellets or a combination of the two, you can choose a capsule filler that meets your specific requirements.

Some of the benefits of filling your own empty capsules are:

  • It is an affordable option as long as you have a suitable capsule filling equipment
  • You can control the quality of the ingredients
  • Using capsules will conceal bad taste of you powder or gel formulations
  • Saves time since you have control over most processes

However, before you start the business of filling your own capsules, ensure you comply with the set rules and regulations within your jurisdiction.

8. Can you Fill Liquid in Empty Capsules?

Always remember that empty gelatin capsules are suitable for powdered formulations.

On the other hand, vegetable empty capsules are suitable for gel or semi-solid formulations.

Normally, liquids tend to form holes on the gelatin capsules, which may cause leakage.

9. Where can you Buy Empty Capsules?

SaintyCo offers high quality and the best empty capsules.

Whether you want gelatin capsules, vegetable capsules or acid-resistant capsules, SaintyCo offers a range of sizes and colors.

Even when you need custom empty capsules with logos, SaintyCo offers a perfect solution.

Contact SaintyCo for MOQ and price.

10. How are Empty Capsules Made?

Empty capsules manufacturing is a step-by-step process which involves the following key stages:

Manufacturing empty capsules

Manufacturing empty capsules – Photo credits: Clinical Gate

Step 1: Preparing Material for Empty Capsules

Whether you want to manufacture gelatin empty capsules or vegetable empty capsules, choose high grade material.

Depending on the type of material, it may require melting, boiling, mixing, etc.

Step 2: Add Dyes and Opacifants

You can add dyes, opacifantsor any other additives at this stage.

The ingredients you will use at this stage depends on the specific requirements of the empty capsules.

Step 3: Feed Material in the Machine

Based on the type of capsule manufacturing equipment, you can pump material or allow material to move via gravity.

Step 4: Capsules Molding Process

Next, you will move the liquid material to capsule shell forming stage.

Here, the machine molds capsules to the required shape and size.

Depending on the configuration of the machine, the machine will use an appropriate mechanism to form capsules with a cylindrical shape.

Next, it will dry the capsules by controlling:

  • Humidity
  • Temperature
  • Air volume

The empty capsule making machines are designed to control all the essential parameters.

Step 5: Discharging Empty Capsules

Once the capsules are dry, the machine strips the two halves of the capsules from pin bars.

Furthermore, it will also trim the empty gelatin capsules.

The process makes it easier to join the capsules back when necessary.

During the entire process, the empty capsule manufacturing machine will control:

i. Size

ii. Moisture content

iii. Thickness

iv. Color

Step 6: Empty Capsule Inspection

Subject empty capsules to the relevant quality inspection and process.

It is to ensure that the empty capsules conform to the required quality standard requirements.

11. How do you Specify Empty Capsules?

Parts of empty capsules

Parts of empty capsules

Whenever you are buying empty capsules, you should specify the following:

i. Type of material of empty capsules

ii. Flavor, dyes, pigments and other ingredients

iii. Quality standard and compliance which may include USP, FDA, I.P. 1996

iv. Size and dimensions

v. Weight and volume

vi. Disintegration time

More importantly, you should know the empty capsules manufacturer.

12. How do you Store Empty Capsules?

Lack of proper storage may cause possible damage of empty capsules.

Therefore, to ensure your empty capsules remain in good shape and condition, you should consider the following:

  • Use original packing to keep the empty capsules
  • You should maintain the temperature range from 59°F (15°C) – 77°F (25°C)
  • Relative humidity should remain within 35% – 65%
  • Avoid high temperature or cycling temperature
  • Keep empty capsules away from steam, how water or direct sunlight

Remember, harsh storage conditions may:

  • Distort shape of empty capsules
  • Shatter empty capsules
  • Make separating empty capsules difficult

Mostly, quite a number of empty hard gelatin capsules should last for about 5 years.

However, failure to follow the recommended procedures may reduce their shelf life significantly.

13. How does Softgel Capsules compare to Hard Gelatin Capsules?

 Softgel capsules vs hard gelatin capsules

 Softgel Capsules vsHard gelatin capsules

Hard gelatin capsules or two-piece capsules and Softgel capsules are popular in most food, medicine and chemical industries.

Here are important aspects you need to know about these two types of capsules:

Hard Gelatin CapsulesSoftgel Capsules
They are made from hard gelatin materialThey are made from soft gelatin or ribbon
Available in two piece which you can separateAvailable as a single piece that hermetically sealed
Best for powder productsBest for gel or oil based products
Manufacturing and filling process requires two different machines- empty capsules manufacturing machine and capsule fillerForming capsules and filling process takes place in one machine as a single process
Capsules are cylindrical in shapeCapsules come in a range of shapes such as oval, round, fish-like, tube-like, etc.
Ratio of gelatin to plasticizer is 1:0.4Ratio of gelatin to plasticizer is 1:0.8

14. What are the Ingredients of Empty Capsules Shell?

Some of the main ingredients of hard gelatin capsules shell include:

  • Animal products such as collagen for gelatin capsule and plant product such as cellulose for vegetable capsules
  • Plasticizers
  • Sugar
  • Demineralized water
  • Opacifier
  • Dye
  • Edible coloring
  • Glycerin
  • Preservative

It is important to note that the amount or type of ingredients will depend on the specific empty capsule you intend to have.

15. What are the Benefits of Hard Gelatin Capsules?

Some of the benefits of empty capsules, which are also called hard gelatin capsules include:

  • Easy to fill with basic capsule fillers such as manual capsule filling machine
  • Less expensive compared to Softgel encapsulation machine
  • You can adapt the hard gelatin capsule to most applications – whether in medical, chemical or food processing industries
  • Easily digestible
  • Longer shelf life which can go up to 5 years

16. Are there Disadvantages Hard Gelatin Capsules?

The most common disadvantages of hard gelatin capsules include:

  • They are not suitable for liquid formulations and hygroscopic substances
  • Commonly found in cylindrical shapes
  • Can only disintegrate where there are digestive fluids
  • Capsule may crack during handling when water content drops below 12% to 15%

17. How long does Hard Gelatin Capsule take to Disintegrate?

Disintegration time can take between 3 to 13 minutes.

The rate at which the hard gelatin capsules disintegrate will depend on the amount of plasticizer present.

Of course, this will depend on specific points you intend the hard gelatin capsule to release the drug.

18. How many Types of Empty Capsules are there?

You can classify empty capsules depending on a wide range of parameters such as:

  • Clear empty capsules – these are basically transparent capsules
  • Opaque empty capsules – these are capsules whose opacifying agents make them non-transparent
  • Colored and transparent empty capsules – even though these capsules are colored, they are still transparent
  • Colored opaque empty capsules – these capsules are not only transparent, but they are also colored.

19. What are the Common Defects on Empty Capsules?

Defects on empty capsules

Defects on empty capsules

Some of the most common defects include:

  • Shape defects- these many include dent, mashed, short, long, double cap or bent capsules
  • Color defects – the defects may be due to discoloring, variation, or different colors
  • Appearance defects – some of the common appearance defects include foreign particle, scrape, edge, dirt, split, hole, cracked or telescoped surface
  • Printed mark defects – some of the common defects include an improper mark or no mark

20. What are Acid Resistant Empty Capsules?

Acid-resistant capsules are special types of empty capsules that do not disintegrate in the stomach.

Most of these acid-resistant capsules have an enteric coating that is responsible for the delayed-release property.

Normally, you can use the delayed-release capsules to deliver drugs or medicine for intestinal absorption in the duodenum.

Acid-resistant capsules are not different from the normal hard gelatin or two-piece capsules except for the delayed-release capability.

Furthermore, you can get acid-resistant vegetable capsules and acid-resistant gelatin capsules.

21. Are there Quality Standards for Empty Vegetable Capsules?

Yes.

Empty vegetable capsules must conform to certain quality standards such as:

  • KO & OU Kosher requirements
  • Vegetarian & Vegan Action society Guidelines
  • Halal certification
  • FDA requirements
  • European medical agency requirements
  • European Pharmacopeia
  • United States Pharmacopoeial
  • Japanese Pharmacopeia)
  • European Directorate for Quality Medicine

All these quality standards ensure the empty vegetable capsules are safe for use.

22. Are Empty Gelatin Capsules Safe?

Absolutely.

However, to be sure of the empty gelatin capsules’ safety, you should consider a manufacturer who adheres to the stipulated safety standards.

Remember, the safety will depend on the choice of ingredients or materials of the empty gelatin capsules.

Besides, the empty capsule storage will also determine the degree of safety.

23. What are the best Empty Capsules for Liquid?

You can use empty vegetable capsules for gel and semi-liquid formulations.