training report edited

7/27/2019 Training Report Edited

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Page 1HLL LifeCare Limited , Trivandrum

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.


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2. PRODUCTION PROCESSES

Transformation of tested raw latex to condom taking place in primary production

consists of three major processes.

i) Compounding

ii) Moulding

iii) 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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SOAP

WASHING

STRIPPING

2.4 Japanese Technology Moulding Operation:

MOULDING PROCESS

EDGE

ROLLING

DRYING LEACHING

ANTI-

STICKING

DRYING

FIRST

DIPPING

COMPOUNDING

MOULD

DRYING &

COOLING

HOT

WATER

RINSING

BRUSHING

SECOND

DIPPING

DRYING


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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 condomsin 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 thecondom 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

Characteristics

SS SR ST BRT

Sealing

temperature

160+/-5oC 185+/-5

oC 135+/-5

oC 100+/-5

oC

Machine

speed

60 strips/min 85 strips/min 60 strips/min 40 strips/min

Output in min 60 strips 85 strips 60 strips 120 strips

Line of

operation

Single Single Single Triple

Feeding of

condoms in

slots

Manually Manually Manually Automatic


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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.


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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) Preventive maintenance

ii) 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.


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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 oftubes 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


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to the boiler by another gear pump. The furnace oil is heated to about 120OC

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

(90000 LTS) (2000 LTS)

FURNANCE

OILPRIMARY

STORAGE

SECONDARY

STORAGE BOILER


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SPECIFICATIONS

Feed water:

pH 7.5 - 9.5

Hardness


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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 Balanced-

Opposed 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 ) 1 to 2.5 kg /sq. cm

Air pressure (2nd stage ) 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 1Nos. 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 3067 cu inches

Speed 1500 RPM


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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.


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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 sets1000 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.


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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 internationallyrecognized 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


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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


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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 Burst Volume (Liters)

49 mm 15.82 16

53 mm 18.50 18

In the after packing testing section certain number of samples are subjected toburst 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.


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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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