Project on Productivity Improvement in case of Blister Packaging at GlaxoSmithKline Bangladesh Limited

Training Period: From 30 October, 2011 to 20th November, 2011

th

Submitted to: Mr. Syed Nazrul Alam H R Manager & Head of Security & Administration, GlaxoSmithKline Bangladesh Ltd.

Submitted by: Asma Akhter Farhana Nasreen Priam Salina Akter Shaifa Sultana Refat Tasnim Taizy

Department of Pharmacy University of Science & Technology Chittagong

Acknowledgement
We, the students of the Department of Pharmacy, USTC, would be pleased to say that, we have completed our three weeks Industrial training in GlaxoSmithKline Bangladesh Limited. During this three weeks training period, we were exposed to many new things which were very valuable for us to learn and to carry out with devotion when we will face the real world of working in the future. With deepest respect we would like to express our thanks and profound gratitude to the personnel of GSK Bangladesh Limited who have given us the opportunity to conduct this training in their company. We would like to thank Mr. Rajib Barua (Site Director), Mr. Syed Nazrul Alam (H R Manager), Mr. Tahseen Zakaria (Manager, Training and Administration), Mr. Md. Lokman Hossain (Site Production Manager), Mr. Pradip Kumar Hore (Site Quality Manager) for their kind co-operation to complete our in plant taining program in this industry. Our special thanks goes to Mr. Safwan Bin Alam for his helpful supervision. The support that he gave truly helped the progression and smoothness of our internship program. The co-operation is much indeed appreciated. We will never forget the great appreciation of all other employees of GlaxoSmithKline, Bangladesh for their skillful direction, kind supervision and relentless encouragement all through the period of the internship. We also would like to extend our thankfulness to the Chairman of our Pharmacy Department, Dr.Md. Showkat Ali, for arranging this training for us.

Letter of Transmittal
Date of Submission: December 12, 2011 To, Mr. Syed Nazrul Alam, H R Manager & Head of Security & Adminnistration, GlaxoSmithKline Bangladesh Limited. Subject: Submission of Internship Report. Dear Sir, With due respect, we would like to submit our internship report on Productivity Improvement in case of Blister Packaging at GlaxoSmithKline Bangladesh Limited. We have concentrated our best effort to achieve the objectives of the report & hope that our endeavor will serve the purpose. We believe that the knowledge & experiences we have gathered during our report preparation will massively help us in our professional life. We will be obliged if you kindly approve this effort.

Yours Faithfully, Farhana Nasreen Priam Salina Akter Asma Akhter Shaifa Sultana Refat Tasnim Taizy

SL.No. Topic Name A) Company Profile: 01 02 03 04 05 06 07 B) About GSK Environment, Heath & Safety Site of GSK Quality Management System Good Manufacturing Practice Production Department Quality Assurance Department Project on Productivity Improvement in case of Blister Packaging at GSK Bangladesh Limited. Objective of Study Methodology Discussion About Productivity About Packaging Blister Packaging Machineries Documentation Data Collection Identified Problems & Suggestions Conclusion

Page no.

5 9 10 11 11 12 19

01 02 03 04 05 06 07 08 09

22 22 23 23 30 31 31 35 41

Company Profile
About GlaxoSmithKline:
GlaxoSmithKline Bangladesh Limited carries with it an enviable image and reputation for the past 6 decades. A subsidiary of GlaxoSmithKline plc - one of the worlds leading research based pharmaceutical and healthcare companies, GSK Bangladesh, continues to be committed to improve the quality of human life by enabling people to do more, feel better and live longer. The companys principle activities include secondary manufacture of pharmaceutical products and marketing of vaccines, pharmaceutical healthcare products and health food drinks. In 1949, the company commenced its journey in Bangladesh with its corporate identity as Glaxo in Chittagong as an importer of products from the Glaxo Group of Companies. It started spreading its spectrum from being an importer to a manufacturer by establishing its own manufacturing unit at Chittagong in 1967. The facility till date is considered as one of the centers of excellence in Global Manufacturing & Supply Network of the Group. The global corporate mergers and acquisitions have seen the evolution of the Companys identity in the past 6 decades. In line with mergers and acquisitions the identity changed from Glaxo to Glaxo Wellcome Bangladesh Limited following the burroughs Wellcome acquisition in 1995 and finally to GlaxoSmithKline Bangladesh Limited during 2002 after merger with SmithKlineBeecham in December 2000. The mega merger of the Company enables it to deliver cutting edge advancements in health care solutions. The relentless commitment, setting of standards of ethics and quality backed leading edge technology of the company has built a strong relationship between the stakeholders and GSK Bangladesh. With the ever committed 615 numbers of personnel all over the country, GSK Bangladesh, which now comprises of both Pharma and consumer products, continually strive to meet the GlaxoSmithKline mission to improve the Quality of human life by ensuring healthcare products, health drinks and different corporate social responsibility programs. GSK is committed to develop new and effective healthcare solutions .The values on which the group was founded have always inspired growth and will continue to do in times to come.

Mission Statement:
GSK global quest is to improve the quality of human life by enabling people to do more, feel better and live longer.

Vision Statement:
To grow in the network through the journey of Operational Excellence.

Objectives of GSK:
GSK Bangladesh mainly has two objectives to achieve the goals of the organization. These two objectives are:

1. To maintain the quality on the overall activities of the organization. Quality is at the heart of everything done in GSK- from the discovery of the molecule, through product development, manufacturer, supply and sale. It is the intent of the company to deliver the right products to patients and customer at the right time and cost.

2. To maintain the environment, health and safety of the organization. Environment, health and safety are essential for business ethics, compliance with regulations and avoidance of liabilities and competitive advantage.

Master Organization of Chittagong Site:

Rajib Barua (Site Director) Shahana Ali (Administrative Assistant) Syed Nazrul Alam (H R Manager & Head of securitiv & admin) Pradip Kumar Hore (Site Quality Manager)

Md.Shamsul Alam (Site Finance Manager)

Md.Lokman Hossain (Site Production Manager) M M Shahnewaz Chowdhury (EHS Manager)

Anjan Kumar Das (Site Engineering Manager)

Ashrafur Rohman (Planning & Supply Manager)

Mizanul Islam (Procurement Manager)

Products of GSK Bangladesh Limited:

Environment, Health & Safety (EHS):

GSK Mission Statement explains why they are in business: We at GlaxoSmithKline will dedicate ourselves to delivering innovative medicines and products that help millions of people around the world live longer, healthier and happier lives. For each of us this should be quest-a daily search for ways that we, as individuals, can contribute our time, our talents and our ideas to achieve as a company what is a truly noble mission for the benefit of society. This mission of improving life, cannot be achieved without paying due attention to the health and safety of the employees and to the environment in which the employees operate and people live. Environment, health and safety are vital components of the ethical approach to business.

EHS Guidelines:

The EHS guidelines include the following:

Leadership and Management General EHS Programs Business processes Employee health (physical) Environmental risks

Different Sites of GMS Chittagong, Bangladesh:

Ware house Manufacturing/Production area Engineering workshop Physician sample packaging room Dextrose packaging room Dextrose storage room -lactum testing lab Occupational health care centre Finished goods ware house Solvent store Acid store Covered store Incinerator

Fire ponds Bottle crushing area Scrap yard Trade union building Quality assurance department Cephalosporin block Cloth washing area DM water plant Waste water purifying plant KPI Board Emergency control room Canteens Masque Administrative building

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Quality Management System (QMS):

The QMS is the system for defining and meeting the global quality standards for business. It has been designed to fulfill European Union, FDA and world health organization requirements. These regulatory sources provide the baseline standards that are used to develop and maintain the content of the QMS. The QMS supports the aspirations embodied in the GSK Quality Statement. QMS has eight sections: Management Personnel Documentation Facilities Material &Product Control Process Assurance Laboratory Controls Incident Management

Good Manufacturing Practice:

Good Manufacturing Practice is mandatory for any pharmaceutical industry. It is a local regulatory and compliance which includes the following:

People Plant and equipment Products Procedures Paperwork

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Production Department:
Production department is the most important part of GSK. It is the busiest section. Over here the employees wear the safety uniform for maintaining the quality of the product of GSK. In GSK there are seven sections in the production department:

1. Tablet manufacturing 2. Tablet packaging 3. Topical area 4. Oral liquid area 5. Clean liquid area 6. Cephalosporin Block 7. Dextrose packaging section

Entry to the Production Area:

While entering the production area, the employees or the visitors have to take certain precautions like:

The employees or the visitors have to wear an apron. The employees or the visitors have to wear a cap. The employees or the visitors have to wear a mask. The employees or the visitors have to wear hand gloves. The employees or the visitors have to wear shoe covers. The employees or the visitors have to wear safety glasses.

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Tablet Packaging:
Tablet packaging is the process by which the tablets are suitably packed so that they should retains their therapeutic effectiveness from the time of their packaging till they are consumed. The tablet packaging section in GMS Chittagong is divided into two sub-sections like blister packaging area and strip packaging area. About 24 products are packed in this section. For these products, there are 9 packaging lines - 2 lines for blister packaging, 6 lines for strip packaging and 1 for the bottle filling. Some equipments and products of the tablet packaging section are listed below:

Strip Packaging:

Blister Packaging:

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Topical manufacturing and packaging:

The Topical area relates with the manufacturing and packaging of ointments and creams. The total number of products manufactured in the topical section is 14, among these 6 are creams and 8 are ointments. A summary about the equipments and products of the Topical manufacturing and packaging section is given below:

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Oral Liquid Area:

Oral liquid consists of five sections: 1. 2. 3. 4. 5. Oral liquid manufacturing Oral liquid packaging Bottle washing DM water plant Offline over printing

Oral Liquid Manufacturing:

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Clean Liquid Manufacturing & Packaging:

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Lotrix Cream Area: Under clean liquid area there is another section called Lotrix cream area. This area is separated because Lotrix cream is a very toxic preparation due to the use of 0.5% permethene in it.

Dextrose Packaging Area:

Cephalosporin Block:
Cephalosporin is one kind of antibiotic. It is a -lactum antibiotic. I have broad spectrum of activity. It was first isolated from Cephalosporium fungus. The production area and the lab operation of Cephalosporin group of products are separated from the main production area to avoid cross contamination.

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Quality Assurance Department:

Quality assurance department ensures the proper quality of all the products and raw materials. GSK strongly believes in quality. In the quality statement of GSK, the chief executive officer, Mr. Andrew Witty mentioned that Quality is at the heart of all activities that support discovery, supply and marketing of products to our patients and customer. Quality is critical to building trust with society and therefore to our future business success. From this statement we can see the importance of quality to ensure discovery, supply, patients and customers need and thereby ensuring future business. The quality assurance department is divided into the following sub-divisions:

Quality Assurance

Operational Quality

Lab Operations

Regulatory Compliance & Technical support

Microbiology Lab

Operational Quality:
Operational Quality (OQ) ensures the continuity and maintains the quality of the products. The permission to use the raw materials for production and then to market the product are granted from this department through official letter. All the reports from the lab and the production area come into the operational quality office and then are released from here.

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Functions of Operational Quality: Handling of change control, Deviation Periodic Product Review Final batch release Production and QC floor Inspection, in process controls checks Handling of return goods Handling of customer complaints Retention of finished goods KPI reporting Risk assessment related with product.

Lab Operation:
The function of Lab operation starts after the procurement of raw materials and ends with the release of the packed batches of medicines. At first the raw materials are analyzed to check their quality and only then they are allowed to be used to make the products. Similarly the batches of finished products are first analyzed and only if they are passed by the lab operation, they can be released to the market. Lab operation also performs different tests for waters. To perform these tests the lab operation is equipped with different kind of instruments such as: Karl Fisher Titrator. High Performance Liquid Chromatography (HPLC). Gas Chromatography. IR Spectrophotometer. FT IR Polarometer PH meter UV spectrophotometer Centrifuge machine Viscometer

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Ultrasonic bath Digital orbital shaker Flask shaker Test tube shaker Pipette stand etc.

Microbiological Lab Operation: The main purpose of this lab is to ensure uncontaminated products and environment. To maintain proper quality, it is important to ensure that the product is not contaminated which is not possible without a clean environment. In the lab, various methods are used to test the presence of bacteria, virus, and for particle count.

Equipments: Memmert Incubator Gallenkamp Cooled incubator Suntex 560 Colony counter Laminar air flow cabinet Particle counter Microscope etc

Regulatory Compliance and Technical Support: This part provides all the support for the QA department to move on. It looks over the change in formula of existing products, new products, government permission and all other technical things.

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Project on Productivity Improvement in case of Blister Packaging at GlaxoSmithKline Bangladesh Limited.

Objective of Study:
GlaxoSmithKline (GSK) is one of the worlds leading Pharmaceutical Company and we are very glad and proud that we are given an opportunity to perform our industrial training in such a renowned company, in terms of quality and quantity. We have been able to learn a lot of practical details in this short span of time. Conducting this study is our small attempt to utilize our 4 years educational learning and a short but very useful practical training to find out some useful measures to improve the productivity of the blister packaging line, so that we can offer something back to this company which may be useful for the further improvement of the productivity of the blister packaging.

Methodology of Study:
The study was conducted at the belt no-6 of blister packaging area of the tablet packaging section of GSK Bangladesh Ltd. We have tried to understand the whole process and identify the obstacles that are faced during blister packaging by careful observation and one-to-one discussion with the duty officers, operators and workers involved in blister packaging. The data of the last few days were collected from various records of blister packaging section. Some other useful information were collected from the internet, previous reports, booklet and other information provided by different persons whom we met at GSK Bangladesh Ltd during our training period. Finally, the findings were analyzed and some possible ways to improve the productivity were proposed.

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At the beginning of the study we would like to recall some related fundamental details like the definition of productivity, packaging and others.

Productivity is a ratio of what is produced to what is required to produce it. Usually

this ratio is in the form of an average, expressing the total output divided by the total input. Productivity is a measure of the efficiency of production. The formula of total productivity is normally written as follows: Total productivity = Output quality and quantity / Input quality and quantity

Importance of Productivity:
Every pharmaceutical manufacturer is faced with the challenge of competing in a growing marketplace where quality assurance is paramount and in an economy that requires organizations to continually cut costs. When there is productivity growth, the existing commitment of resources generates more output and income. Income generated per unit of input increases. Additional resources are also attracted into production and can be profitably employed.

How to Improve Productivity:

Pharmaceutical companies can increase productivity in a variety of ways. The most obvious methods involve automation and computerization which minimize the tasks that must be performed by employees. Recently, less obvious techniques are being employed that involve ergonomic design and worker comfort.

Packaging:
Packaging has been defined as the means of ensuring the safe delivery of a product to the ultimate consumer in sound condition at the minimum overall cost. In other words, packaging is the science and arts of, and the operation involved in, the preparation of articles for carriage, storage and delivery to the customer. In short, Packaging sells what it protects and protects what it sells.

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Types of Packaging:
Primary packaging is the material that primarily covers the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Secondary packaging is outside the primary packaging which is used to contain the primary packages together. Tertiary packaging is the final packaging which remains outside the secondary packages. It is useful for bulk handling, warehouse storage and transport shipping.

Role of Packaging:
A pack has a number of functions to perform during its life, including storage, carriage, display, sale, use etc. A pack is the economical means of providing for a product presentation protection identification/information convenience/containment portion control until such time as the product is used, paying due attention to any relevant environmental issues. Pharmaceutical products generally require a standard of packaging which is superior to that of most other products in order to support and comply with their main requirements, i.e. proven efficacy, safety, uniformity, reproducibility, integrity, purity with limited impurities, minimum side-effects coupled to minimum product liability risks and a goodshelf life stability profile. All these should be considered during pack design.

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Types of Tablet Packaging:

There are two types of tablet packaging available in the Pharmaceutical industry: Strip packaging Blister packaging

Strip Packaging:
This is formed by using two heat sealable foils placing tablets in pockets formed automatically in the machine. In GSK Bangladesh Ltd we have observed to use aluminum and paper for strip packaging.

Blister Packaging:
Blister pack is a term for several types of pre-formed plastic packaging used for small consumer goods, foods, and for pharmaceuticals.

The primary component of a blister pack is a cavity or pocket made from a "formable" web, usually a thermoformed plastic. This usually has a "lidding" seal of aluminum foil or plastic.

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Blister packs protect medications from environmental influences such as atmospheric humidity, oxidation and microorganisms, as well as mechanical influences during transport. In addition to this, they allow for easy ingestion of tablets directly from the package.

The blister packaging is better than conventional packaging in the following terms:

product integrity product protection tamper evidence reduced possibility of accidental misuse patient compliance.

The four basic components of pharmaceutical blister packages are the forming film, the lidding material, the heat-seal coating, and the printing ink. Forming films account for approximately 8085% of the blister package and lidding materials make up 1520% of the total weight of the package. Because the forming film and the lidding material form an integrated package, they must match precisely.

Forming film: The forming film is the packaging component that receives the product in deep drawn pockets. Factors influencing package production and speed of assembly must be taken into account, including heat sealing properties and the ease of cutting and trimming formed blisters. Plastic forming films such as PVC, polypropylene (PP), and polyester (PET) can be thermoformed, but support materials containing aluminum are cold-formed.

Lidding materials: The lidding material provides the base or main structural component upon which the final blister package is built. Hard aluminum is the most widely used push-through lidding material.

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Heat-seal coatings: Heat-seal coatings provide a bond between the plastic blister and the printed lidding material.

Printing inks: Printing inks provide graphics and aesthetic appeal. Printing inks must resist heat sealing temperatures as high as 300C without showing any discoloration or tackiness (blocking).

Types of Blister Packaging:

Two basic types of pharmaceutical blister packages exist:

In one variety the cavity is constructed of clear, thermoformed plastic, and the lid is formed of clear plastic or a combination of plastic, paper, and/or aluminum foil. The process is known as thermoforming. In GSK Bangladesh Ltd the ALU-PVC blister packs are prepared for the products like Grisovin FP 500mg tablet, Panadol-Extra tablet, Glaxipro 500mg tablet, Fluvin-OD 50mg & 150mg tablet and Peflon tablet 400mg.

The other type of package contains aluminum foil as an essential component of both web and its cavity is created by cold stretching (ALU-ALU). This process is known as cold-forming. Products that require the highest degree of protection are packed in an all-foil package. Cold-formable foil is finding favor because it is the only material that provides a 100% barrier to moisture, oxygen, and light, allowing an extended product expiry date. The principal disadvantages of cold form foil blisters are: the slower speed of production compared to thermoforming; the lack of transparency of the package (a therapy compliance disadvantage); and the larger size of the blister card (aluminum can not be formed with near 90 degree angles) and often allowing the product to shift inside the blister. In GSK, Norain Cap 20mg and Zantac tablet 150mg are packed in Alu-Alu packs.

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Process of Blister Packaging:

The sequence involves heating the plastic, forming it into blister cavities, loading the blister with the product, placing lidding material over the blister, and heat-sealing the package. This can be a simple manual process, or it can be partially or fully automated.

Blister packaging machines typically operate with intermittent motion. The essential parts and functions of an intermittently operating packaging machine include the following:

1) The unwinding station: The unwinding station supplies the forming films at a rate corresponding to the speed of the packaging machine.

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2) The heating station: The heating station raises the temperature of the plastic forming films to a level suitable for deep drawing. Forming films containing the polyvinyl chloride (PVC) support material are heated to 120140 C. Forming films containing aluminum are not heated before the forming process.

3) The forming station: The forming station forms the plastic blister cavities via compressed air or die plates. Films containing aluminum are formed with mechanical forming tools only.

4) The feeding machine: The loading area fills the blister cavities with product.

5) Aluminum foil: The lidding material is supplied from another unwinding station at a rate corresponding to the speed of the packaging machine.

6) The sealing station: The sealing station heat-seals the lidding material to the forming film that contains the product. All heat-sealing methods mate the blister and lid under constant pressure for a specified time, during which heat is supplied. The mating surfaces fuse and bond, setting almost instantaneously when heat input stops. Depending on the type of machine, the sealing temperature typically ranges between 140 and 340C.

7) Cooling station: The cooling station is necessary with all forming films.

8) Coding station: Packages are labeled, notched, and then marked with a batch number at the coding station. The perforating device makes a cross-shaped perforation along the sealing seams.

9) The punching station: the packages are then separated into sheets that typically contain from 10 to 20 individual blisters. The vision system checks the filled packages for defects.

10) Product.

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Blister Packaging Machinery:

Modern thermoformfillseal machines can operate at speeds <800 packages/min. Today, much of the emphasis in improving production is placed on applying microprocessor controls that electronically connect the filling and forming equipment with other downstream machinery for cartoning and wrapping. These controls also feed tablets or liquids into the unit-dose blisters, ensuring that an exact volume is put into each. Modern machinery also uses integrated vision systems to help ensure the accuracy of the fill and the integrity of the product in the blister. These machines have become quite versatile and can readily accommodate several types of lidstocks and basestocks, allowing the manufacturer to obtain better compatibility between the medicine and its packaging material as well as better patient compliance.

The Machine Under Study:

The blister packer in belt no 6 in the blister packaging section of GMS Chittagong is manufactured by Hoong-A Corporation, Korea. The machine is capable to produce 69 packs per minute. The Hoong-A blister packer is attached with a conveyor belt to convey the packs from the primary packaging area to the area where the packs are counted and then undergo secondary and tertiary packaging.

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Documentation:
GSK is very conscious in terms of documentation. For each and every work there is an up-to-date SOP (standard operating procedure). So that, each work is done within procedure. We also observed some other documents like BPR (Batch packaging record), BOM-BPR (Bill of material-batch packaging record), log books, team sheets etc.

Collected Data: Daily Output of Grisovin FP 500 mg

Ti m

8-9

9-10

10-11

11-12

12-1

1-2

2-3

3-4

4-5

Total

17.11.11 19.11.11 20.11.11 21.11.11

Da

te

200 150 250 200

200 150 250 250

280 250 250 250

271 250 250 93

100 103 83 200

240 250 307 250

200 300 275 207

249 200 325

300 217 300

2040 1820 2290 1450

Remarks: Standard output is 2500-3000 packs per day.

Curve of daily output:

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Team Sheet
Product name: Grisovin FP 500mg, Batch No: 407,408 16/11/2011 17/11/2011 19/11/2011 20/11/2011 21/11/2011 Machine Setting(heat) 20min Batch/product change 20min Foil change/Adjustment Lack of Bulk Lack of overprinting items Late arrival of transport Defective Bulk Vessel change Early Finish 10min Manpower Shortage Tea Break 30min Machine trouble trouble(Mechanical/Electrical) Power failure Lack of compressed air gvvavavacuum/Compressed Jet/Batch printing trouble air Humidity problem Others Total 1 hr 20min Date 16.11.11 Batch No 403 404 17.11.11 404 405 19.11.11 405 406 20.11.11 406 407 21.11.11 407 408 Packed Filled 248 1042 951 1089 903 917 1083 1207 793 657 8:30AM 5:00PM 8:40 4.20 8:30AM 5:00PM 8:40 7.10 8:20AM 5:00PM 8:30 7.10 88 S.P.M 8:20AM 5:00PM 8:40 7.20 20min 20min 20min 20min 30min 20min 30min 20min

N/A

10min 30min

10min 30min

10min 30min

1min 30min 3hr*

N/A N/A N/A 4hr 20min

1 hr 20min

1 hr 20min

1 hr 30min

Start Time 8:20AM

Finish Time 5:00PM

Gross Net Speed Time(hr) Time(hr) 8:40 7.20

*Remarks: The machine was stopped for 3 hours at 21/11/2011 due to sealing plate problem

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Production Equipment Log register (External):

Date 16.11.11 Product Grisovin FP 500 mg Batch Start no Time 403 8:20AM Finish time Production Details Production Stopped

404

10:00AM Batch Completed 10:10AM 10:20AM Line Clearance&Batch Change 10:20AM New Batch started 4:30PM Production Stopped 4:30PM 5:00PM Machine Cleaned 8:20AM 12:00PM 12:50PM 5:00PM 6:00PM 8:20AM Production Stopped Batch Completed Line Clearance&Batch Change New Batch started Production Stopped Machine Cleaned Setting Production Started Batch Completed Line Clearance&Batch Change Production Started Production Started 12:00PM 1:00PM 5:00PM 6:00PM Batch Completed Line Clearance&Batch Change New Batch started Production Stopped Machine Cleaned Production Started

17.11.11

Grisovin FP 500mg

404 405

12:00PM 12:50PM 5:00PM 19.11.11 Grisovin FP 500 mg 405 8:10AM 8:20AM 404

12:10PM 12:45AM 1:00PM 1:05PM 8:10AM

20.11.11

Grisovin FP 500 mg

406

407 407

12:00PM 1:00PM 5:00PM

21.11.11

Grisovin FP 500 mg

407

8:20AM

408

11:00AM Batch Completed 11:00AM 11:20AM Line Clearance&Batch Change 11:20AM New Batch started 2:00PM 5:00PM Production stopped due to Sealing Trouble 5:00PM 6:00PM Machine Cleaned

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Production Equipment Log Register (Internal):

Date 16.11.11 Product Grisovin FP 500 mg Batch Start Finish Production Details no Time time 403 10:00AM 10:20AM Batch Completed 10:00AM 10:20AM Line Clearance&Batch Change 10:20AM Production Started 4:50PM Production Stopped 5:00PM 6:00PM Machine Cleaned 8:10AM 8:20AM M/C Heat & Setting 8:20AM 8:30AM 405 12:00PM 12:50PM 5:00PM 8:10AM 8:20AM 8:30AM 406 12:50PM 1:10PM 5:20PM 8:10AM 8:20AM 8:30AM 407 12:00PM 1:00PM 5:00PM 8:10AM 8:20AM 8:30AM 408 8:30AM 12:00PM 12:50PM 5:00PM 6:00PM 8:20AM 8:30AM 12:50PM 1:10PM 5:20PM 5:50PM 8:20AM 8:30AM 12:00PM 1:00PM 5:00PM 6:00PM 8:20AM 8:30AM Leak Test OK Production Stopped Batch Completed Line Clearance&Batch Change Production restarted Production Stopped Machine Cleaned M/C Heat & Setting Leak Test OK Production Started Batch Completed Line Clearance&Batch Change New Batch started Production Stopped Machine Cleaned M/C Heat & Setting Leak Test OK Production Started Batch Completed Line Clearance&Batch Change Production started Production Stopped Machine Cleaned M/C Heat & Setting

404

17.11.11

,,

404

19.11.11

,,

405

20.11.11

,,

406

21.11.11

,,

407

Leak Test OK Production Started 11:00AM Batch Completed 11:00AM 11:20AM Line Clearance & Batch Change 11:20AM Production started 2:00PM 5:00PM Production Stopped due to sealing trouble 5:00PM 6:00PM Machine Cleaned

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Identified Problems & Suggestions:

One of the important factors for the line is machine utilization. Everyday each machine remains, busy, blocked, idle, down, or in setup for a certain time. Upgrading line controls and adding inspections at specific stages of blister packaging will reduce wasteful, inefficient line processes such as: 1. Downtimes 2. Rejects 3. Rework 4. QA sampling.

The higher the overall busy time on the line, the greater line productivity.

Curve of downtime:

Remarks: The machine was stopped for 3 hours at 21/11/2011 due to sealing plate problem

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From the collected data and spot observation, we tried to identify the problems that prevent the achievement of standard output which can be as follows:

i)

Interrupted power supply: The interrupted power supply seemed to be one of the major problems in GMS Chittagong which affects the overall productivity of the company as well as the blister packaging. We observed a great number of load shedding per day and each time the power goes off it takes almost 1 minute to start the generator backup. And then it takes about 4 minutes to restart the blister packer. It hampers the overall production.

Suggestion: We have come to know that many other industries in Bangladesh use the natural gas or other fuel to generate electricity on their own through their individual power plants. This ultimately saves a lot of money than buying the electricity from PDB and solves the problem of load shedding as well. If the machine has consistent utilization then there will also be limited equipment start-up and shutdown, potentially lowering the downtime and increasing the productivity.

ii)

Tea break/lunch break: Whenever operators went on lunch or break, the line was shut down. This prevented achievement of the 90 minutes per shift of equipment run time. Again the workers are observed to return not in time after the breaks which caused some more loss of time.

Suggestion: It can be suggested that breaks should be staggered to maximize uptime by keeping equipment functional throughout the shift. The workers should be motivated to return in time.

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iii)

Empty pockets and broken tablets: We have observed that the workers were manually detecting many blister packs with empty pockets or with broken/defective tablets. It was very much time consuming and tiresome to check each and every pack manually and there remains every chance of error. In addition, as these defects were identified after the primary packaging, the packs were needed to be deblistered to recover the tablets which needed extra work and the packing materials were wasted.

Suggestion: The latest vision inspection technology can be installed for more precise and efficient inspection of products (empty pockets, product verification, component count, color identification, incorrect placement of product or presence of foreign material etc.) prior to sealing. The modern Visual Inspection systems make use of high speed, high resolution camera's and a digital image processing system to analyze the pictures that pass in front of the lens. When properly set up and configured, visual inspection systems have proven to be very versatile and reliable.

Benefits of implementing the Visual Inspection Systems Avoid product wastage and rework Provide 100% inspection of the blisters Automatic ejection of defective blisters to avoid non-conformations Improve control, reliability, and accuracy of the inspection process. Provide real-time data and statistics on production quality. iv) Absenteeism: Absenteeism is one of the major obstacles of production. It requires about 10 workers in the belt no-6 for its smooth running. But almost everyday 1-2 workers remain absent for various reasons which prevent the achievement of the desired output at due time. Again many of the elderly workers remain sick for a reasonable period. To fill up these gaps, workers are shifted

37

from other department to the blister packaging section who may not be fully skilled for the job. So the productivity is decreased.

Suggestion: The workers should be regularly motivated to minimize the absenteeism. The worker with minimum absenteeism can be rewarded to encourage them to work more. If anyone is found to enjoy unnecessary leave repeatedly, proper action should be taken against them. Finally, some more energetic, skilled workers can be employed to enhance the productivity.

v)

Mechanical error : We have observed that the Hoong-A blister packer in belt no6 has become older and it frequently suffers from mechanical problems like sealing plate problem, web/channel jam, cartridge failure, machine stoppage, defective embossing, defective printing etc.

Suggestion: Machines should be monitored regularly for smooth running and an engineer can be present all the time to immediately combat any mechanical problem that occurs during production. The operators should be more careful in handling the machine. It will be even better if the machines can be replaced with some newer versions.

vi)

Delayed counting: The blister packs are manually counted and inserted into the carton by the workers. It was seen that often the workers cannot count the blister packs as faster as they are produced. These packs are counted afterwards which takes a lot of time. So it takes more time to start the next batch even after the packs are produced.

Suggestion: If an autocounter is introduced then the workers will not have to count them manually and thus they will have packed them in the final carton faster and will be able to move forward for the next batch.

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An autocartoner can also be introduced so that even the time required for cartoning will also be saved and there will be greater productivity.

vii)

Leak test: The tablet packaging section of GSK Bangladesh Ltd employs methylene blue dye test as a means of leak test for the blister packs. We found this test to be messy, destructive, time consuming and operator dependant which really does not befit the technical excellence associated with modern pharmaceutical manufacturing. The subjective nature of the test and variance in setup across packaging lines can lead to validation issues. This, combined with the needless destruction of good packs and the intensive reliance on the operator, leads us to believe that the time has come to replace this method with a more suitable alternative. One of the attractions of the blue dye test is the low cost of the equipment required but the real cost of running the blue dye test can be seen only when the cost of disposing the waste and lost production is considered.

Suggestion: A blue dye test alternative using innovative laser technology (pin hole detector) can be used as part of the quality assurance processes. It replaces the traditional and messy blue-dye testing method of checking for leaks using a liquid test that rendered the packs and their contents un-useable regardless of whether they have a hole in them or not. A pin hole detector can detect leaks as small as 7 microns in individual blister pockets using scanning technology. So all samples which 'pass' the test can be re-introduced to the packaging line, thus reducing waste and increasing productivity. Again, as this is an automatic process, no man-hour would be wasted for this test.

viii)

Overtime: In GMS Chittagong, overtime is one of the major factors related to production & packaging. Sometimes, overtime may be required to fulfill the dayto-day target. But it is not encouraging for the all the times as it is seen in this company. It requires the company to pay extra allowances to the workers which ultimately hampers the productivity and ultimate profit. Different machineries

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problems, downtime, shortage of required number of skilled man power and sometimes the workers interest ultimately precipitate the need for overtime.

Suggestion: To minimize the overtime problem, more number of efficient man powers may be recruited. The employees should be motivated, monitored and supervised to utilize their normal working hours properly and complete their work in time. Steps to be taken to minimize the absenteeism which can contribute to minimize the overtime issue.

After performing this study we have come to the conclusion that further automation and computerization of the blister packaging process and increased supervision will be able to boost-up the productivity of the blister packaging section. Finally, we would like to convey our gratitude to all the persons who helped us through this study as we find ourselves very glad and privileged to get the opportunity to do a project in the GMS Chittagong, GlaxoSmithKline Bangladesh Limited. We wish the blister packaging area will be more developed and overcome all sorts of problem reaching its targets beyond the boundaries. We would consider ourselves worthwhile and be extremely pleased if our effort serves to anyones help.

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Conclusion:
GlaxoSmithKline Bangladesh Limited has maintained a good rank in both Bangladesh & all over the world compared to the other Pharmaceutical Companies. GSK Bangladesh Limited has gained a good momentum over time and it maintains its momentum through ensuring quality of the products to the market & its consumers. It also has developed innovative products which other pharmaceutical company has not yet produced.

During the three weeks internship program at GlaxoSmithKline Bangladesh Limited, almost all the departments have been observed by us. This internship program allowed us to gain a lot of practical knowledge & helped us to visualize our four years academic course almost in a month only.

As we observed that GSK is so conscious about its products quality, it rejects all those products which do not satisfy their standard & never gives approval for its market release. The employees also strive hard to maintain the standard quality & minimize the defective products through the standard operating procedure (SOP) of the company.

As an intern we have gained practical experience as well as industrial knowledge from the employees of the company & the people of GSK has motivated us for dealing a better professional life in the field of pharmacy here after.

We are proud to have a first hand knowledge from a company like this. We pray for the onward development of GlaxoSmithKline Bangladesh Limited.

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