THE RUBBER TAPPING PROCESS

Malaysia is blessed with many positive factors that enhance and promote the natural plantation environment. The positive contributing factors of the tropical climate, adequate rainfall and sunshine act as catalysts to produce the finest latex in the world.

THE MANUFACTURING PROCESS

To ensure this, a comprehensive Quality Assurance System has been implemented and is continually monitored internally and routinely audited by an outside third party.

Latex Condoms produced by our company are in compliance with all major standards such as the Class 2b of the Medical Device Directive in Europe and the CFR21-175, 105, 177 and 2600 of the Food and Drug Administration in the US.

Receiving of pre-vulcanized latex for production use:

Incoming Inspection:

1. pH/TSC/Chloroform
2. Comparison of COA

Mixing:

The production starts with the preparation of latex by mixing the latex and water according to the strict specifications before it is transferred into the dipping tanks.

In-Process Inspections:

• pH/ TSC
• Latex Temperature/ Stir Speed/ Skin
• Oven Temperature
• Film Uniformity
• Beading Roller Position & Condition
• Leaching Water pH
• Collecting Water pH

Dipping Process:

The dipping line consists of a continuous chain with 2 rows of glass condom forms.

The condom forms are first cleansed by brushing and rinsing.

Then the condom forms are dipped into the first tank of latex and withdrawn slowly so that a thin, smooth, uniform film is achieved.

The latex on the forms is then dried in an oven before being dipped into a second tank of latex.

After the second dipping, the condoms are dried again in a another oven to ensure the beading area is dried before being formed.

The condom forms are then moved to the beading station where the open end of the condom is beaded. The condoms are then dried and fully vulcanized in a third oven.  

The condoms are leached in a tank containing a diluted ammonia solution to remove excess proteins and chemicals from the condoms.

The leached condoms are then stripped from the forms by water before being collected into baskets.

Powdering:

A powdering solution is prepared in the powdering tank and the condoms are transferred from the baskets to the tank.

After being stirred and then drained the condoms are put into a spinner to remove excess water and make them ready for the drying process.

Tumble drying:

Next, they are placed into a dryer and tumbled dry for approximately 45 +/- 5 minutes at 70 +/- 20 degrees Celsius.

The still hot condoms are then cooled down in the dryer for 15 +/- 5 minutes. Once the condoms are cooled, they are removed and placed into poly bags to form batches.

Forming batches:

The batch number, manufacturing date, time and tank number of latex are recorded for future reference.

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Dimension Measurement Tests:

The Quality Assurance Department conducts the dimension measurement tests. These tests measure condom width, thickness and length, to ensure that they meet required standards.

Water Leakage Test:

QA Inspectors carry out water leak testing. Filling condoms with 250ml of water and dipping them into a salty water. If current passes through the condom, it reveals the leakage.

Air Bursting Test (unaged):

The air burst test inflates the entire condom like a balloon, stretching all of the latex until it bursts. The purpose is to measure the condom strength. The air burst test measures the maximum amount of air the condom can hold (burst volume, liters) before breaking.  It also measures the air pressure level (kPa) inside the condom when it breaks.

Air Bursting Test (aged):

A limited number of condoms are also required to be tested after oven conditioning at 70 C degree. This test is intended to check for major formulation or vulcanization errors

Tensile Testing

Ring specimen perpendicular to the length direction of the condom with a die having cutting edges 20 ± 0.1mm in the region of not less then 70mm from the open end. It measure at least 17MPa in tensile strength and 700% for ultimate elongation before and after ageing. 

100% Electronic Testing:

All condoms are individually tested and rolled through electronic pinhole testing machines, which separate accepted and rejected condoms into different containers.

The electronic testing device is checked for accuracy on a continual basis by mixing off colored, imperfect condoms, into the batch and making sure that they are discarded, by the testing device, into the reject container.

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Foiling:

The condoms are lubricated by an automatic lubricant dispenser and then sealed with the aluminum foil by sealing machines.

The condoms can be foiled in rectangular shape or square shape.

Normally, the inkjet information of lot no. and expiration date are printed online during foiling.

Foil Package Integrity:

Once again a Quality Assurance Inspector separates a sample of the finished batch.  Using a special vacuum chamber the integrity of the foil wrapped condom is tested. The process begins with a defined vacuum strength generated in the vacuum chamber, the condoms are added, the vacuum is increased until the foil wrap fails.  This is done to measure the strength and integrity of the foil wrap and seal.

 

Packing:

The foiled condoms are packed according to customer requirements and stored in a cool dry place awaiting final shipment. (examples: 3 pack, wallet pack, bulk pack etc...)

All condoms are finally packed in shipping cartons, strapped and properly labeled.

Unit container or consumer packages are designed and made of such material that the condoms are fully protected during transportation and storage and do not inflict any mechanical / physical damages when the containers and packages are opened.

Storage:

Packed condoms are stored in cool and dry finished goods warehouses. The condoms are stored on separate pallets according to lot number.

The condoms are now ready for shipment.

1. Length Measurement
2. Width Measurement
3. Thickness Measurement
4. Bursting Volume and Pressure Test
5. Freedom from holes
6. Freedom from Visual Defects
7. Oven Aging Test
8. Aged Bursting Volume and Pressure Test
9. Packaging & Labeling
10. Package Integrity

1. Latex
2. Cornstarch Powder
3. Silicone Lubricant