1.

INTRODUCTION

Hindustan Latex (HLL) commenced its journey to serve the Nation in the area of Health Care, on March 1, 1966, with its incorporation as a corporate entity under the Ministry of Health and Family Welfare of the Government of India. HLL was set up in the natural rubber rich state of Kerala, for the production of male contraceptive sheaths for the National Family Planning Programme.

The company commenced its commercial operations on April 5, 1969 at Peroorkada in Trivandrum. The Plant was established in technical collaboration with M/s Okamoto Industries Inc. Japan. Two most modern Plants were added, one at Thiruvananthapuram and the other at Belgaum in 1985.

The production facility at Peroorkada has emerged as one of the largest single manufacturing Plants in the world for the production of Condoms, with a capacity to produce over 1 Billion Condoms a year. With the addition of this capacity,

HLL today has an annual production capacity of 1.316 billion condoms.

HLL is today a multi-product, multi-unit organization addressing various public health challenges facing humanity

The manufacturing unit at Peroorkada was set up by HLL in 1969 with the technical collaboration using Japanese technology. The plant which has an annual production of 1066 million pieces condoms undergone continuous modernization over the years. The facility is equipped with modern production, inspection and quality control machines and equipments in international quality norms. Condoms manufactured by this facility have CE Mark and can meet a range of international quality norms by WHO 2003, ISO 4074:2002, SANS ISO 4074, ASTM D 3492, GOST- 4645-81 etc. Page 1 HLL LifeCare Limited , Trivandrum

2. PRODUCTION PROCESSES
Transformation of tested raw latex to condom taking place in primary production consists of three major processes. i) ii) iii) Compounding Moulding Vulcanizing

2.1 Compounding Production starts with compounding. The required characteristics of latex is obtained during compounding. This is achieved by the addition of fixed quantity of compounding chemicals in dispersion to raw latex in large mixer tanks. The dispersion is prepared by using ball mill/sand grinder/pearl mill/attritor mill. The compound is then heated (pre-vulcanized) by introducing steam to the jacket of mixers. After the predetermined time ,the heating is arrested by introducing chilled water to the jacket. The compound latex from the mixer tank is then transferred to supply tank and is mixed with required amount of 1% ammonia water solution in order to control the properties like TS (total solid) content, viscosity etc. Along with this colour pigments are added, depending on the type of condom required. Then it is kept for a predetermined time for ageing before supplying for moulding. The whole compounding time takes 11.5 hours to complete.

2.2 Compounding Chemicals And Their Functions

Stabilisers used are Ammonia Solution, Casein solution, potassium salt of fatty acids etc. are added to prevent, or retard decay or spoilage of latex under the conditions of use or storage.

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Vulcanising agent used is Sulphur.

Chemical that permits the acceleration of Vulcanisation reaction.

Zinc oxide is used as the vulcanizing activator

Compounding chemicals that is used to prevent deterioration of the properties of the film caused by oxidation or by natural ageing

Surface-active substance used to facilitate the suspension of solid compounding materials in a liquid medium and to stabilize the dispersion thereby produced.

Pigments are added to the compounded latex at the supply tank stage to impart colour to the condoms.

2.3 Moulding of Condoms

Primary Production includes:

Two types of moulding machines are available Eight machines: M1, M2, M3, M4 (PLANT-A) MA, MB (PLANT-B) M5, M6 (PLANT-C)

The machines are named in the order in which they were assembled. The machines with the nomenclature consisting of alphabets, i.e, MA,MB,MC,MD are those which are designed by the original manufacturers (Okamoto & Ritcher) and are imported while those with the nomenclature with numbers, i.e,

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M1,M2,M3,M4,M5 &M6 were indigenously fabricated and commissioned by our production department.

1)

German Technology (M/s Ritcher Hi-Tech) Two machines: MC, MD (PLANT-B)

2)

Japanese Technology (M/s. OKAMOTO RIKEN GOMU CO)

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2.4 Japanese Technology Moulding Operation:

EDGE ROLLING

DRYING

LEACHING

DRYING

ANTISTICKING

SECOND DIPPING

STRIPPING

MOULDING PROCESS

DRYING

SOAP WASHING

FIRST DIPPING

BRUSHING

COMPOUNDING

MOULD DRYING & COOLING

HOT WATER RINSING

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2.5 Vulcanisation of Condoms Uncured natural rubber is sticky, can easily deform when warm, and is brittle when cold. In this state it cannot be used to make articles with a good level of elasticity. The reason for inelastic deformation of unvulcanized rubber can be found in its chemical nature: rubber is made of long polymer chains. These polymer chains can move independently relative to each other, which results in a change of shape. By the process of vulcanization, crosslinks are formed between the polymer chains (Vulcanisation consists of creating a sulphur crosslink, i.e., a bridge is being formed by one or more sulphur atoms between adjacent polymer chains) so the chains can no longer move independently. As a result, when stress is applied the vulcanized rubber will deform, but upon release of the stress, the rubber article will go back to its original shape.Vulcanising Induces extensive changes in the physical properties of natural rubber and is brought by reacting the rubber with sulphur

2.6 De-hydration Operation

Post-Stripping, the condoms are dehydrated in a wire mesh barrel. The silica slurry is dried off from the stripped condoms by the dehydrator and leaves the dry powder on the condom to serve as a dusty material during further processing. The condoms are dried using hot air so that the products can pneumatically be carried to the vulcanising machine barrels without sticking anywhere in the carry-hose.

After the moulding operation the unvulcanized condoms move to vulcanization stage.

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3. ELECTRONIC TESTING DEPARTMENT (INSPECTION)

FUNCTION The function of Electronic Testing Department is to test and roll up the condoms in Electronic Pinhole Testing Machine (EPT). The ETD is class 100000. ETD receives condoms manufactured by HLL as well as from other sources, passed by HPQC for testing in EPT machines. Testing is done after a minimum maturation time of 3 days of the passed lots from HPQC. The Condoms are covered on the mandrels fixed to a conveyor chain. Chain speed is 902 per minute. These condoms pass through a conductive rubber flap, which is part of the high voltage-testing unit. High voltage is applied to the condom through the rubber flap. The moulds are rotated at a speed of 2-4 times across the high voltage tester. The HV tester applies 900-1650 V DC. The detecting unit identifies the condom as good or bad. A rolling brush rolls up the tested condoms. The rolled condoms are pneumatically stripped off into the Good and Bad collection trays.

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4. PACKAGING SECTION
4.1 Primary packaging The input materials using in this process are foil, silicon oil, and naked condoms. 1. Strip packing This is the most important process in packing operation, which is doing in strip packing machine. There are mainly two types of machine are using based on type of jaws for sealing and they are (a) rotary seal jaw machine & (b) flat seal jaw type machine. The most important parameters monitored in these machines are sealing temperature, machine speed, pressure and the position of condoms in the slot of machine. There are 103 machine are using in our plant for packing in which 55 machines are of single rectangular, 15 are single square machines, 27 are static square machines and 6 are BRT machines. Comparison of these different machines are shown in table

Machines

SS

SR

ST

BRT

Characteristics Sealing temperature Machine speed Output in min Line operation Feeding condoms slots Page 8 HLL LifeCare Limited , Trivandrum of Manually in Manually Manually Automatic 60 strips 85 strips Single 60 strips Single 120 strips Triple 60 strips/min 85 strips/min 60 strips/min 40 strips/min 160+/-5oC 185+/-5oC 135+/-5oC 100+/-5oC

of Single

After setting up the machine parameters, condoms will be picked from the crate and is placed over clean machine bed. As the conveyor moves condoms are placed on conveyor plates. As the foils moves through the heated press rollers, the condoms also get inside the layer of foils and since there are recess in the press rollers, the condoms are safely positioned inside the pocket formed by the recess and gets sealed all around and carries out in continuous strip. As the condoms moves through the slots of machine and it carried towards the silicon nozzle area, where oil is supplied to the strips with the help of a pump. The quantity of silicon oil applied in to the strips is depends up on the type of schemes and is shown in the table

After the oil pumps in to the top of condoms in the strips, sealing will take place on the four side of the foil and then cut it in to different series as per the requirements of the customers.

Secondary Packing The materials as well as machines required for secondary packing operations are wallet, carton, box, leaflet, catch cover, shrink wrapping machine, hoping machine, HDPE sheet, weighing machine, wallet coding machine and strip packed condoms. Page 9 HLL LifeCare Limited , Trivandrum

5. ENGINEERING DEPARTMENT

There are four sections under engineering department: MECHANICAL UTILITY ELECTRICAL INSTRUMENTATION

MECHANICAL SECTION This section plays a key role as a service section to keep the plant and machineries in satisfactory condition. Types of maintenance:

Broadly maintenance is divided into two categories:

i) ii)

Preventive maintenance Breakdown maintenance

Preventive maintenance

Activities carried out to prevent failure or detect failure before it develops into a failure. Preventive maintenance involves lubrication, planned overhauls, regular cleaning and adjustments.

Breakdown maintenance Activities carried out to correct the failure or break down after the occurrence of breakdown/ fault. Breakdown analysis is also done. Production department calls for the maintenance department to rectify the defect. This economical for non-critical equipments whose downtime and repair cost are less. Page 10 HLL LifeCare Limited , Trivandrum

6. UTILITY
Utility section is one of the supporting sections providing the facilities required for the production processes. It maintains generation and distribution of all utilities associated with production process.

The major functions are, To generate and supply steam in desired quantity To supply sufficient quantity of process water and chilled water to various sections To generate and supply compressed air to various sections what ever required. To maintain diesel engine of DG set in good condition To maintain all mechanical weighing balances in good condition To maintain all AHUs in good condition To maintain Forklifts in good condition.

Utility Equipments

6.1 Boilers

Presently there are two boilers- Kesselpack and, of 8 TPH each. Both are furnace oil fired, horizontal, packaged, 3 pass, fire tube boiler. Kesselpack is used continuously and the efficiency is 80-81%. Thermax is used whenever the requirement exceeds 8 TPH, and the efficiency is about 76%. The number of tubes in Thermax boiler is 188 and of Kesselpack boiler is 242. Boiler operation: Both the boilers are furnace oil fuelled. The furnace oil is transferred from the main tank to an over head tank by means of a gear pump. Then it is pumped on Page 11 HLL LifeCare Limited , Trivandrum

to the boiler by another gear pump. The furnace oil is heated to about 120 OC using a heat exchanger heated by steam. For cold start electric heater is also provided. The furnace oil is then atomised using primary air from a centrifugal blower and introduced into the chamber. The secondary air is supplied for combustion. Time, temperature and turbulence should be maintained to burn the furnace oil effectively. For cold starting of the boilers diesel is used initially and ignited using a spark.

THREE PASS FIRE TUBE BOILER

FURNANCE OIL PRIMARY STORAGE

SECONDARY STORAGE

BOILER

(90000 LTS)

(2000 LTS)

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SPECIFICATIONS

Feed water: pH Hardness Total solids 7.5 - 9.5 <5 ppm 400 ppm (max)

Blow down water pH TDS 10-12 5000 ppm (max)

General steam Supply pressure 7.5 9.15 kg/sq-cm (115.60-130.05 psi) Flue gases Temperature 200-250 OC

Furnace oil Temperature 95-125 OC

Back-Up UPS 440V

6.2 Air Compressors Air compressors are used to provide compressed air to various production departments. Pressurised air is used in various pneumatic controls. The diaphragm pump used in compounding section, pneumatic controls in vulcanization, stripping of condoms in ETD and pneumatic cutting system in packing machines use compressed air. Various tests in QA like BV/BP also use compressed air. Page 13 HLL LifeCare Limited , Trivandrum

There are three compressors of Chicago Pneumatic make. Two are of 75 HP and 1 of 60 HP. The compressors are Horizontal, Two Cylinder, and BalancedOpposed Models. The two cylinders are connected with an intercooler cooled by cooling towers. The compressors provide oil free air. An air drier is also provided.

Operational parameters Air pressure (1st stage ) Air pressure (2nd stage )

1 to 2.5 kg /sq. cm 3.5 to 6 kg /sq. cm

6.3 Water Supply

There are two main water tanks of 650 KL and 1450 KL. An over head tank of 60 KL is also present. A softening unit for process water is also present. The water supply is from Thiruvananthapuram Municipal Corporation.

6.4 DG Set There are currently 5 DG sets of 1000KVA, 500 KVA, 2 Nos. 320 KVA and 1 Nos. of 200 KVA. The 1000 KVA generator set uses a 16 cylinder Diesel Engine KTA 3067G. K V Engine T Turbo charged A After cooler G - Generator Displacement Speed 3067 cu inches 1500 RPM Page 14 HLL LifeCare Limited , Trivandrum

6.5 Forklifts

Fork lifts are used to load/unload and transport goods within the factory premises. There are 2 forklifts. Both are of Godrej make of one is 3 tonne and other is 5 tonne, diesel powered. Maintenance of these forklifts is given as AMC to Godrej.

6.6 Power supply: 11 KV HT supply from KSEB is fed through a high tension VCB (Vaccum circuit breaker) panel. Its then stepped down to 11KV/440V by distribution transformer. Its then connected to a main voltage panel through 1250A ACB (air circuit breaker) as an incomer. Bus couplers are provided in the main panel so that the system does not get affected in case if the transformers are out of service. The main vaccum circuit breaker (KSEB supply and generator supply) is provided with an interlocking system. The distribution system consists of mainly 3 nos. of 630 KVA, 11KV/433V step down transformers. The total connected load of the system is 1450 KVA and the contract demand is 950 KVA. The readings of the various meters such as TOD (time of the day) meter, HT ammeter, HT voltmeter, LT ammeter and LT voltmeter are recorded in the daily log sheet at 1 hour interval basis. Page 15 HLL LifeCare Limited , Trivandrum

6.7 Electrical Utilities:

11KVA HT Feeder. 3 nos of 630 KVA 11KVA/433V step down Transformer. HT Panel, Main Panel Board, Sub Switch Boards(SSBs) Energy Meters which indicates the amount of Electrical energy consumed. DG sets 1000 KVA 1 no; 500 KVA 1no; 200KVA 1nos,320 KVA 2 nos ACBs (Air Circuit Breakers), OCBs (Oil Circuit Breakers),VCBs(Vaccum Circuit Breakers) that helps to protect the equipments connected to it.

3 phase Capacitor Bank that helps to improve the power factor . AVR (Automatic Voltage Regulators) to sustain the voltage fluctuations. Industrial UPS (Uninterruptible Power Supply) Equipments also helps to avoid production loss maintain the voltage to the desired level incase if the voltage fails

7. INSTRUMENTATION
Activities Repairing and maintenance of process control -equipments. Calibration of test and measuring equipments as iso -standards. Preventive / proactive maintenance. Scheduled maintenance. Break down maintenance - by shift personnel. Technology up gradation / modification works. Maintenance of internal telephone communications. Page 16 HLL LifeCare Limited , Trivandrum

8. SAFETY DEPARTMENT

Device pre accident strategies and conduct safety audit & inspection. Introduce work permit system, detailed accident analysis, fire fighting operation etc. To prepare procedure for emergency preparedness & response method. Ensure implementation of the procedure by concerned departments. Identify and evaluate environmental aspects and fix environmental objectives and targets. To monitor the concentration of ammonia, dust and noise: To provide guidance for identification of proper personnel protective equipments by concerned departments. Measurements will be made on a quarterly basis To maintain safe height of materials.

9. PURCHASE DEPARTMENT
The aim of the department is to procure right quality of material in the right quantity at the right time from the right supplier for the right price and thus to ensure that materials and services are made available to have uninterrupted Production and Packing as per plan. Procurement of raw materials, packing materials, equipments, spare parts and services to maintain continuity in respect of supply of materials to support production schedule and the companies operation are done here. The department also deals with developing good and reliable vendors and ensuring healthy buyer-vendor relationships. Also the evaluation of vendors based on their ability to supply products in accordance with the organizations requirements is done by this department.

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10. STORES DEPARTMENT

Objectives

To receive material goods and equipments and check them for identification.

To keep the traceability of all materials received in Stores in each level.

Issue of material to various sections as per their requirements.

Control of inventory.

Proper storage, preservation and handling of finished goods. Optimum usage of cubic space. To initiate purchasing cycle in the appropriate time so that materials required are never out of stock.

11. QA An Introduction:
The primary function of the QA department is to ensure the quality of product at all stages of production, so that overall rejection of the final product could be kept at a minimum. Thereby we ensure that our product meets the internationally recognized standards of quality. ISO 4074 (standard for production of natural latex male contraceptive condoms) is the basic standard for condom production at Peroorkada Factory. Condoms are Class 2-B medical device. Generally we follow two standards for the testing of condoms; they are Schedule-R of the Page 18 HLL LifeCare Limited , Trivandrum

Drugs and Cosmetics Act & WHO 2003. Sampling plan is derived from ISO 2859-1. The other major functions of the QA department is given below: Defining and documenting quality system procedures Establishing quality management systems as per the guidelines of ISO 9001-2000 Contract reviews regarding the requirements of the customer and our own capabilities. Keeping the identification and trace ability of the product. Application of the SQC (statistical quality control) techniques. Overseeing / Conduction of the receiving inspection, in process inspection and final product inspection on sample basis. Conducting monthly GMP audits in all departments Tendering of batches for Govt. supply Keeping the test status for the product at every stage of manufacturing. Thorough review and disposition of non-conforming products. Maintenance of reserve samples by QA department for the life of the product. Offering external batches for inspection. Participating in inter-lab trials Collecting customer feedback Corrective and preventive actions.

Half Product Testing In this phase the batch number and lot identity is given. From the lot samples are selected and samples are subjected to visual inspection, dimensional & leakage checking.

Dimensional Check includes: Average Weight Length Page 19 HLL LifeCare Limited , Trivandrum

Width

The visual inspections makes sure that defects like wrinkles, bad edge roll, scratches, twisted condoms, discolouration, sticking, bad print, weak spots, bump cut, non vulcanized etc. If such defects are present they are rejected and these defects are shown on screen so that they are met with immediately.

QA Tests Conducted

The QA tests are conducted on samples from the following two phases:

Before Packing After Packing

30 samples from a lot of electronically tested condoms are taken for before packing testing. 24 out of these are tested for water leakage. If 2 or more samples fail, the lot is rejected. Remaining six samples are set for burst test.

Width 49 mm 53 mm 15.82 18.50

Burst Volume (Liters) 16 18

In the after packing testing section certain number of samples are subjected to burst test and certain number are subjected to water leakage test. Numbers of samples to be selected are determined by an empirical formula: N = (n+1) where n is the total quantity

In burst test the lot is rejected if 10 or more fails within minimum pressure of 1 KPa. Page 20 HLL LifeCare Limited , Trivandrum

In the water leakage test lot is rejected if 2 or more fails. The next test is after ageing test. Samples are placed in ovens at 70C for 3 days for condoms having expiry date of 3 years and 7 days for condoms having expiry date of 5 years. Then the condoms are subjected to lubrication quantity test and package seal test.

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