Plant Training in Advanced Chemical Industries Limited (Part 2)

Existing products development:

Product Development Department also develops the formulation of the existing products. They do the following works-

• Increasing the quality of the product.
• Prevention of any type of problem existing in the product.
• To save time and cost.
• Increasing the patient acceptance.

Activities done by product development department:

•       Preformulation study of the active ingredients, which includes collecting all available information of the active regarding its formulation its formulation , physical, chemical, therapeutical, toxicological, microbiological (if necessary) data.
•       Trail of the product in small scale that includes the entire manufacturing procedure.
•       Comparative study on market sample for newly developing product and for existing product.
•       Physical and chemical analysis of the newly developed products.
•       Accelerated Stability Study of the new products.
•       In case of INN products, raw material analysis and method development for dissolution procedure.
•       Process Validation of 3 consecutive batches.
•       Stability & chemical analysis of the products those are included in compendia (BP/USP) which often include HPLC analysis.

Reformulation of Existing Product:

•       study on market complaint products to minimize complaint, which include-
•             Root cause analysis of the complaint,
•             Reformulation of the product,
•             Trail,
•             Chemical analysis and
•             Stability.

      Shape change, coating color change or changing other parameters of any product that includes reformulation of the product, trail chemical analysis and stability.

      Source evaluation of active ingredients and excipients that needs several trails for individual product.

Documentation:

•       BMR preparation of all new products.
•       BMR of existing product due to the batch size or other parameter.
•       Stability data (accelerated and real time) preparation for export.
•       Technical part of Recipe.
•       Correction of Product Brief and Annexure.
•       Process validation documentation.

Steps of the development of a new product:

Step-1: Product information from marketing department along with   ………..

 necessary attributes such as

        – Source

        – Sample

        – Q.C test (potency. LOD etc)

Step-2: Pre-formulation study of the active drug and excipients.

– Chemical activity.

– Function.

– Interaction.

– Boiling point.

– Contraindication.

– Moisture content etc.

Step-3: Collection of raw materials of active drug and excipients.

Step-4: Different trials for development of a stable, effective and active

              formulation.

Step-5: Drug administration formalities include:

a) Submission of recipe to drugs administration which contains –

– Strength

– Dosage form

– Contraindication

– Dissolution

– Description

– Precaution

– Side effect

– M.R.P.

– Indication

b)  Sample admission (if INN product)

c)   Approval of sample from drug administration and inclusion of

      D.A.R. and license no.

d)   Submission of Inclusion Dossier.

e)   Final approval for commercial production.

 Step-6:  Pilot trial and accelerated stability testing.

 Step-7:  Readjustment If necessary.

 Step-8:  BPR preparation if every aspect is satisfied which contains:

– Product name

– Code

– Size

– batch no

– Theoretical yield

– Batch size

– Annexure etc.

 Step-9:  Transfer to production department commercial production.

Quality Assurance

Department

uality Assurance is an organized department in ACI Pharmaceuticals Ltd. which deals with ensuring the quality of the product up to the end user. This department plays important roll to maintain the quality of product. QA issues the release or reject order of product by analyzing QC reports.

Activities of Quality Assurance Department are given below-

• Approval of source
• Checking of Dispensing operation
• In process checking of all production area
• Product sampling , release
• Product complaint handling
• Supplier’s performance review
• Conducting quality audit
• Perform all type of Validation activities
• Document preparation, editing, control etc.
• Retention sample collection, archiving, monitoring, retrieval etc.
• Product quality review(Annual/Periodic)
• Artwork preparation, checking, finalization for packaging material
• Preparation of certificate of analysis (COA) for finished formulation and finished API.
• Establishing manufacturing methods and SOPs covering entire operations and their regular up-dating.
• Communication of every aspects relating to quality to all relevant persons for early positive action.
• Ensuring product Stability

 Quality Control

Department

uality Control Department at Advanced Pharmaceutical Industries (ACI) Limited is to keep the quality up at their products and responsible for the day-by-day control at quality within the company. This department is stuffed with scientist and technicians who assess and assure that entire production process has been completed satisfactorily and satisfied all the aspects of GMP.

Working Division of Quality Control Department:

• Analytical section
• Microbiology section
• Packaging section

Analytical Section:

Analytical section of Quality Control Department performs analytical tests. Analytical tests are mainly of two types as follows:

• Quantitative
• Qualitative

Stability Study

Mainly for finished products, Quality Control Department performs stability study. Aim of this study is to ensure that all batches of the released products are maintaining within specification limits throughout their entire shelf life.

Stability study is performed according to International Conference on Harmonization (ICH).

 Real time study for climate zone 3 & 430º C ± 2º C temperature

65 ± 5% Relative Humidity

Accelerated study40º C ± 2º C temperature

75 ± 5% Relative Humidity

 An intermediate stability study is also performed at 30º C ± 2º C temperatures and 65 ± 5% relative humidity. If 30ºC ± 2ºC temperature and 65 ± 5% is the long-term condition, there is no study required for intermediate condition.

Tests performed in QC department in ACI-

A. Test for tablet and capsules-

1. Loss on drying at 105ºC(3hr)/ Moisture content by KFR
2. Disintegration test
3. Length/diameter
4. Width
5. Thickness of 10 tablets
6. Friability test
7. Dissolution test
8. Uniformity of weight
9. Appearance of tablets or capsules
10. Average hardness of tablets
11. Assay by titration/ spectrophotometric /HPLC/AAS method

B. Tests for raw materials:

                    1. Appearance and odor

                    2. Solubility

                    3. Identity (complies/ not complies)

                    4. Melting point

                    5. Weight per ml

                    6. Acidity/ alkalinity

                    7. Limit test

                    8. Chloride

                    9. Sulphate

                    10. Copper

                    11. Iron

                    12. Arsenic

                    13. Lead/ heavy metals

                    14. Loss on drying at 105⁰C (3hrs)/water content by KFR

                    15. Appearance of solution/ Clarity & color of solution

                    16. Assay-

                                    a. Chloride

                                    b. Spectrophotometric / Titrimetric /HPLC

                                    c. Residue on ignition/ sulphated ash

                                    d. Related substances/ Chromatographic purity

                                    e. Microbial limit

C. Tests for LCO / Gel / Dry syrup / drop:

                    1. Identification of active ingredient

                    2. Identification of Hydroxy benzoates

                    3. Microbial contamination (satisfactory/ unsatisfactory)

                    4. P^H value

                    5. Water per ml at 20± ⁰C, gm

                    6. Viscosity

                    7. Sedimentation test

                    8. TOTAL SOLID

                    9. Color content

                    10. Alcohol content

                    11. PCA content (Parachloro aniline)

                    12.Assay (Spectrophotometric/Titrimetric/HPLC)

D. Test for WFI-

1. Contents of vial/ bottle
2. Sterility test
3. P^H value test
4. Ammonia test
5. Nitrates test
6. Chloride test
7. Sulphate test
8. Acidity/ alkalinity test
9. Oxydizable substances test
10. Hevay metal test
11. Ca & Mg test
12. Residue on evaporation
13. Conductivity test
14. Water content

Machinery in Quality Control Department:

 1.HPLC,QAD 023Shimadzu, Japan2.HPLC 515&2487Shimadzu, Japan3.UV Spectophotometer3000 4.IR Spectophotometer  5.Optical PolarimeterAA-5 6.Microprocessor Ph mteterPh 539 Rs 7.Microprocessor Ph mteterHanna ph 210 8.UV visiable SpectophotometerUV-1601PCShimadzu.9.Karl Fischer Titrator, metter teedoDL31 10.Karl Fischer Titrator, metter teedoDL 18 11.Automic Absorption Spectroscopy  12.Vibrator,Edmund buclerKl-2 13.Analytical electronic balanceGF-300Sartorius AG, Germany14.Milting point Tester,buchi Melting pointB-540 15.sonicator

 Machinery in Quality Control Department:

16.Magnetic Stirrer  17.Tablet Hardness & Diameter tester6 DSchleuniger Pharmatron18.Water Purification SystemAlpha-Q 19.Brookfield ViscometerDV-I 20.Disintegration TesterSK-32020Shin Kwang machinery co.Ltd

21.Dissolution TesterERWEKA DT-700 22.Dissolution TesterERWEKA –DT6L 23.Test sieveB.S41024.Abbe Refratometer 3T25.Thermostart vacuum Oven Oven Townson & Mercer Ltd. Crodon

 Microbiology Section

Microbiology section of Q.C department is performed many microbiological tests. Microbiological tests cover many types of test, like microbial limit test, bioassay of antibiotics etc. Tests are performed basically Sterile Test & Non- Sterile test.

Activities of microbiological section-

• Microbial limit test of raw materials and finished products

1. 1.      Total aerobic bacteria and fungal count.
2. 2.       Detection of pathogens like; Salmonella sp, Escherichia coli (E. coli),Salmonella sp, Pseudomonas aeruginosa, Staphylococcus aureus.

• Microbial assay of raw materials and finished products.

• Environmental monitoring Test-

1. Settle plate technique
2. Air sampling by Renter Centrifugal Sampler (RCS)
3.   Swale test

Note: Environmental Monitoring Test-

• Bacteria needs 3 days for getting result
• Fungus needs 5 days for getting result.

• Sterility Test
• Growth Promotion Test

• Bacterial Endotoxin Test or Bed Test

• For Injections the test are perform mainly:

• Bed Test
• Sterility Test (14 days, if pass then LAL test)

Note: Sterility test are performed for viable microorganism and Limulus Ambiocyte Lysate (LAL) test are performed for non – viable Microorganism)

• For WFI the test are performed mainly:

• BAT Tes

Medium used:

• For bacteria—-Using Agar (ISA) Medium
• For Fungi——-SDA

Autoclaving temperature:

• 121 C at 15 psi for 15 minutes. Usually 1.3 Hours need to reach this temperature in autoclave

Incubator Temperature:

• 30-35C for Bacteria for 1-3 days usually.
• 20 C-25 C for Fungi for 1-3 days usually.

Media are using in Microbiology Laboratory:

Eosin Methyline blue Agar(EMB Agar)

 Brillant Green AgarBismuth Sulphate (Modified)

 Bismuth sulphate Agar

 Lactose Broth

 Mannitol Salt Agar

 Violet Red Bile Agar

 Sodium chloride crys.pur

 Mannitol salt Agar

 Di-Sodium hydrogen Phosphate Anhydrous

 Brillant Green Bile2% Broath

 Di- Sodium Hydrogen Phosphate Dihydrate

 Fluid Thioglycollate Medium

 Potassium dihydrogen Phosphate

 Sabourud Chloramphenicol Agar

 Salmonella Shieglla Agar

 Triptoa Soa Agar

 Triple SugarIron (Agar) (TSI)

 Equipments in Microbiological Section:

AC-220VTaiwanAutoclave-SystecQAD-95(A)160LGermanyIncubator-heat and Cooled IncubatorQAD 45,

QAD-74

QAD-75  RefrigeratorQAD-73 ToshibaParticle Counter   Laminer Air Flow Bench430-CS  Vortex mixer   Incubator (Small)   Hot Air OvenQAD-51

Heraeus-Steriliging Oven

Speedy Autoclave(Verticle Type)

340Chamber Dia: 300 mm

Working Depth:700mm

Capacity:50 L

AC:220V.2.5KW

Laboratory Cooling Incubator-FricellQAO-118 GermanyIncubator-8

Packaging Section

  Quality Control Department performs the following tests for packaging materials:

• Shipping carton

Weight, dimension, thickness, appearance

• Plastic cap

Appearance, weight, length, diameter, volume, capacity

• Dropper

Appearance, weight, length, diameter, volume, capacity, adaptability with bottle, carton and plastic cover

• Mask tape

Appearance, width, adhesiveness

• Water measuring flask

Appearance, weight, length, diameter, capacity

•  Spoon (Plastic)

Appearance, weight, length, diameter, capacity

• Bottles

Height, neck diameter, body diameter, weight, overflow capacity, machine acceptance, light transmission

(10% allowed)

• Inner carton

Height & level, description, weight dimension

• PVC/PVDC

Color, width, thickness

• Label & Literature

Product name, generic name, batch number,

manufacturing date, expiry date, M.R.P,

High Performance Liquid Chromatography (HPLC):

Introduction;

High-performance liquid chromatography, HPLC is a popular method of analysis because it is easy to learn and use and is not limited by the volatility or stability of the sample compound. The information that can be obtained includes identification, quantification, and resolution of a compound.

 Principle

A liquid mobile phase is pumped under pressure through a stainless steel column containing particles of stationary phase with a diameter of 3-10 mm. The analyte is loaded onto the head of the column via a loop valve and separation of a mixture occurs according to the relative lengths of time spent by its components in the stationary phase. It should be noted that all components in a mixture spend more or less the same time in the mobile phase in order to exit the column. Monitoring of the column effluent can be carried out with a variety of detectors.

Applications:

      The combination of HPLC with monitoring by UV/visible detection provides an accurate, precise and robust method for quantitative analysis of pharmaceutical products and is the industry standard method for this purpose.

      Monitoring of the stability of pure drug substances and in drugs in formulations with quantization of any degradation products.

      Measurement of drugs and their metabolites in biological fluids.

      Determination of partition coefficients a p^Ka values of drugs and of drug protein binding.

Advantages:

      Easily controlled and precise sample introduction ensures quantitative precision.

      HPLC is the chromatographic technique, which has seen the most intensive development in recent years leading to improve columns, detectors and software control.

      The variety of columns and detectors means that the selectivity of the method can be readily adjusted.

 Mechanism of UV spectroscopy:

• Prepared sample solution at very
• Lower conc. usually several mgm or mg level
• Poured into UV cell which is cleaned
• With alcohol and the sample solution
• Which is to be detected
• At first blank (only solvent) and standard are
• placed into UV spectrophotometer
• and absorbance is taken in specific wavelength
• Standards are replaced with sample
• Absorbance was taken and determined the amount by using equation.

METER DOSE INHALER

eter Dose Inhaler (MDI) plant of  ACI is highly sophisticated and dosages form,  Inhalers are manufactured in a separate, well equipped building that is different from the other. Different areas of manufacturing floor are separated by clear glass partition and other relevant facilities. Involving manpower in this section are ten members with production officer.

The production area is near about sterile area and considered as Class-10,000 area. This area has been restricted for general visitors. A special entrance procedure and special clothing are required to enter in the production area. SOP is Tag in all wall in this department.“HEPA” filter are used for room class maintaining.

Product running during visiting:

Brodil HFA 100 mcg inhellers (Packaging)

Batch no: LK-1

Number of Product Running now in ACI-12.

Materials are required for MDI production:

• Active
• Sarfactants
• Solvent—-Absolute Etahnol
• Propalent….HFA134 Alkane

Tests are performed for MDI are given below:

• Assay per Accuation
• Deposition of  Dose
• Uniformity of Delivering Dose
• Water Contents
• Leak Test

Packaging materials Source:

• Can  and actuator come from England come from
• Valves come from –PPI Germany.
• Packaging levels are providing from “Moni printing” from Bangladesh

Raw Materials Source:

• Sulbutamol sulphate comes from –India

Machineries Used in MDI Plant

Model-AGITADQSpain100L,Rpm- Max  733,Using Rpm Now-380   Pamasol filling & crimping machineSwitzerland800-1000can/hr  -Ink jet printerFrance-   Can Cleaning Machine (Semi Automatic)India Maharshi- Spray checker machine + lebel machineIndia   -Propalant tank 54 KgElectronic balance (Two Pitch)

Shimadzu Corporation, Japan220gm Max

10mg MinWater Bath Machine

Weight Check Machine-OCSGermany

Automatic Lebeling machineMumbai(India)

During visiting we have seen the following product:

In dispensing section:  

In dispensing area the disinfectants are used for cleaning are mainly:

• IMS
• 100PPM Chloride Solution

Dispensing Unit is organized by:

• Sartorius Balance
• Pass Box
• Hepa filter
• Epoxy Paint Wall
• Positive air pressure difference between rooms to room or corridor is 15 pound.

The parameters of dispensing area of ophthalmic:

 Hepa (High Efficiency Particulate Air )At rest “C” ClassFirst Room: D class maintained

Operation “B” ClassSecond Room: C Class maintained

Third Room: B Class Maintained

Machinery used in Ophthalmic Section:

(180º C for 1 hour,120º C for 15 min at 15 pound pressure)

Holland03.OlympusSterilazation by dry heat.

(160º C for 1 hour,180º C for 20 minutes) India04.Bulk and white ChmaberFor  visual specification  05.StillmassFor WFI production Italy06.Sartorius Balance

Note:  We did not see The Eye drop machine and vial filling machine.

                                                 ————————————–

NEW SOLID SECTION

Number of Existing Rooms in New Solid Section:

Washing area-II

Room facility of New Solid Section:

• Air Lock system
• H-VAC system exist
• GMP maintained
• D- class
• Floor: U-Treat
• Wall: Sand witch panel-fire proof,Gmp as rule, Surface smooth,tempreture proof

Dispensing area:

Dispensing area is consisted by the following section:

• Raw material receiving area
• Dispensing-I
• Dispensing-II
• Dispensed materials  store-I
• Dispensed materials  store-II
• Utensil store
• Office room
• Hepa pressure-40psi
• Humidity–40
• Temperature 23.6C

Running in New Solid Section during Visiting:

Compression section in new solid department of ACI:

Machine nameOriginModel /weightCapacityPunch Type& No.Compression  Section I:

IMA active KilionGermanyE150plus / 1500 KgE150plusB /26Compression  Section II:

IMA active KilionGermany

Machinery exists in Granulation Section of New Solid Section:

FG3001060L50Hz0.3-0.7 pa50-1501000-2900 RpmChina

Coating section in new Solid of ACI:

 RPM:

 Spray Gun:

 Nozzle

 Paristaltic pump Pressure:

 Orgin:

 Coating Section ISejong

300kg124(12” distance from bed)Size:1mm0.1-200PsiKoriaCoating Section IIGlant GC smart

5 (6” Difference from each Gun To Each Gun ) 1 feet distance from bed to guns

India

Packaging Machine in New Solid section In ACI:

            Noumber of MachineModel;

 Serial no:

 Wt:

 Power Source: 415 Vol

 Phase-

 Dimension-

 Orgin: Hoonga2 MachinesHM U6S5M0000553500Kg415 Vol50HZL5600,

W-1140m/m

H-2240m/m

Koria

Buchon Automatic Blister Machine2 MachinesWIDFR-AIVW-D400198p-#5

Miscellaneous machines in new solid section of ACI:

Leak testingModel:

T/75 GMP

By jabs Pharma (Local Machine)

Avery Berket(In Sorting Room)

Paste preparation Vessel   India

Vibro Shipter

Now Mesh size: 20 (changeable mesh screen)

India

Bin Blender 15

800LChina

 Product running in mixing and blending section:

 Active

 ExcipientsParicel-20E/C Tablet core242 .881 kgRabiprazole Sodium-Inn1.Mannitol BP

Magnessium Oxiade USP

Crospovidone USNF

Starch 1500USNF

5.Croscarnellose sodium

6.Sodium laurayl sulphate

. Disodium hydrogen phosphate disodium bp   8.Microcrystalline cellose BP

Collodal silicon dioxide USNF

Involving machines for this product in this section:

40min24 Vibro shifter  24

 PENICILLIN DIVISION

Number of rooms in penicillin section:

Office room, Aseptic area, Stripping room, Packaging room, Store room,-1 rack,

In ACI Penicillin unite has two parts:

 i) Parental-includes vial & ampoule filling and sealing

ii) Non-parental-includes dry syrup and capsule filling & sealing

Batch Number: Lk-27,lk-28

Instruments: For this section the following instruments are used-

Machineries used in penicillin department:

Pen – 14 2Denver Electronic Balance, ID No.-14 Pan

Capacity- 3100.0 gm

Pen – 17

3Shifter machine

4Drum blender

19/minute

5Filling machine, Hauser ogerOrigin: Canada

capacity:5060/minute  6Sealing machine

Origin: India

capacity:5060/min,

Machineries used in Penicillin:

7Sejong. auto capsule filling and sealing machine

korea, Sejong Pharmatec Co. Ltd40,000/min

SF-40

8Duclean capsule polishing machine

9Ganson stripp packaging machine

3,000 10Tablet balanceChina2000 gm

11Hot air sterilizer,E.CHUNG industries company, Taiwan

PEN- 07

Machineries used in Penicillin:

ES-S95OF14THACKARY, moist and heat sterilizerIndia Pen-24

Mixing procedure:

 The mixing was done as per following steps-

1. In mixing room, sugar was passed through the 24 meshes of sieve with using shifter machine and main active ingredient was passed through the 40 meshes.
2. Then sugar was divided into two parts
3.  Half of the sugar was added with active and excipient ingredients
4. Then the rest half of the sugar is added with them
5. Then this mixer is blended into drum blender for one hour.

Filling:

In filling section Humidity: 40ºC-50^ºC  and Temperature: 20º-30⁰C are maintained here.

Parts  of Sejong encapsule filling machine:

1. Shell hopper
2. Orion
3. Plate hopper
4. Powder hopper
5. Powder disk
6. Rejected chamber
7. Locked chamber
8. Outing area
9. Air pressure

Polishing Room:

Through this machine capsule are polished here and than affected or unsatisfacted capsule are rejected manually. This work is performed on a table through selecting 10 or 20 tablets and through visual inspection affected or unsatisfacted capsule are rejected.

Problems found: Capsule physical damage, Shell cutting.

Important notes:

• Person sensitive to Penicillin should not allow to work.
• During dry syrup preparation of moisture sensitive products the humidity is maintained
• For parental preparation the raw materials come in sealed aluminium container which are opened in aseptic condition and before opening they are cleaned with chlorine solution to free from microbes.
• The size of membrane  filter, hepa filter, and modular or pre-filter used are 0.2m, 0.3m and 0.3m respectively.
• Vial are sterilized at 250⁰C for 1 hour and Ampoule are sterilized at 121-125⁰C for half hour.
• WFI is prepared by heating at 300⁰C temp and then condensing and after that it is Filtered
• Through “HEPA” filter air change is done 20 times per hour
• Liquid filtration is done through 0.2m pore size.

                                                         ———————————

ENGINIARING DEPARTMENT

ACI Limited has an independent engineering department for looking after production and utility machineries. Responsibilities of engineering department are to install, maintain, handle and solve all types of problems such as Chemical, Electrical, Electronic and Mechanical.

Function of Engineering Department in ACI limited divided into three (3) ways-

• Utility
• Maintenance
• Project development

Engineering Department-

1. Power house
2. Compressed gas system
3. Chiller system
4. DM water plant
5. Central heat, ventilation and air conditioning system (HVAC system)
6. Stem generation and supplied plant
7. Effluent treatment plant

Power house of ACI-

ACI Ltd has an own complete power supply plant, which is consider as the heart of the factory. The electricity supplies from DESA substation which supply 248 KW. The plant has its own back up secondary power system because of emergency stands by generator.

The power plant of ACI consist of-

1. 1.      Gas generator:  They have four generators operate by using purified gas of which one has capacity 1,145 KW and other three have 1,600 KW, 380 KW & 1,600 KW. (Origin: USA)

12 cubic fit gas is needed for per KW output. “ACI” using gas generator since 1992.

Diesel generator: They have four diesel generators, which capacity are 224 KW, 1,000 KW, 1,060 KW, 52 KW. They have also other two diesel generator, which capacity is 513 KW & 451 KW. (Origin: USA) 0.5 liter Diesel is needed per KW output.

DM Water plant-

ACI has two well established DM water plant. At first the water is dematerialized by reverse osmosis which reduces the mineral contents about 90% and then passed through the ion-exchange resin. The advantages of reverse osmosis are-

1. To decrease regeneration time
2. To decrease chemical using
3. To decrease conductance above 90%

Process-

 In first time ACI collects water from river but now a day the plant has its own water supply from 600 feet deep tube-well and treated that water for getting de-mineralized water.

Notes:

• Two storage tank, 4000 liter capacity
• Per day production: 9800 liter
• Per month production: More than 400000
• Conductivity range are kept in below 1, now conductivity range : 0.62 µ sem/cm
• Ph range are kept in 6-7, now Ph range: 6.4
• Clean all equipments by hot water 85º C

1. Second water treatment plant, New plant (capacity: 4,0000 liter) is given bellow-

Notes:

• Pre-treatment and post-treatment are involved in this plant
• This water plant is used for WFI and washing for Ampoule and Vial
• Clean all equipments by hot water 85º C
• Conductivity range are kept in below 1
• Ph range are kept in 5-7

Steam generation unit of ACI-

1. Steams are generated from the boiler. There are two types of boiler. In  ACI  Fire Tube boiler are used ( Capacity: 5500 kg using 80% of total capacity, Stem: 40-120 Psi, Origin: USA)

1. Fire Tube boiler
2. Water tube boiler

The boiler supply the following things-

1. Steam
2. Hot water
3. Distilled water
4. Water for injection (WFI)
5. Water for bottle washing
6. Water for oral liquid preparation

The boiler or steam generator from “USA”. It has a capacity of 5500 kg. There are also water softeners, which convert hard water to soft water then pass water into boiler is LP gas from “Titas Gas”. Temperature need to produce steam is (130-140)⁰C and pressure 80-120 Psi (Pound per square inches). The capacity of boiler is due to proper maintenance of the machine.

1. Water is supplied into Steam producing tank
2. Heated at 100⁰ C
3. Produced steam
4. Supplied to respective area where required.
5. Mild steel pipe line are used for supplying the water from boiler to production and other departments

Effluent Treatment Plant-

ACI has got ISO 140001 certificate for environmental policy. So as a part of their, commitment, all the effluents are released after well treatment

Maintenance:

Maintenance will be done in ACI limited by the following chart-

1. Planning for maintenance
2. Requirement of skilled and trainer manpower (personnel)
3. Availability of required materials (parts of machines)
4. Execution of work

Project Development:

Engineering department also take part in project development. Recently ACI develop the plant for new solid department and MDI. These developments also take care under the supervision of engineering department.

SUGGESITIONS

The monthly observation in “Advanced Chemical Industries Limited” operates us to think in a practical way for the proper running of a plant with maintaining all the standards related to cGMP.

Albeit it is a super class plant, we may impart some suggestions to rectify some its observable problems to ensure the product safety as well as human safety in the plant.

The suggestions are:

• The GMP has to be followed in old department fulfilly.

• Semi-automatic machine should be replaced by automatic machine.

• It would be better if it is possible to feed the hopper for compression automatically instead of manually.

• It would be better if there is totally different section for cream, ointment, paste.

• The space of “Cephalosporin Department” should be expanded.

• The “Cephalosporin Department” should be separated in accordance with the “Advanced Chemical Industries Limited” image.

 CONCLUSION

he Advanced Chemical Industries (ACI) Ltd. is the leading pharmaceutical company of Bangladesh. This company manufactures products not only for the market of Bangladesh but also for the international market because they manufacture products having higher quality. They maintain “GMA” in the production area and also they have well developed SOP. Besides they do IPC properly that is very important thing for manufacturing quality products.

We are very much delighted as we have came in contact with the “ACI” family during our Internship with them and we also very much impressed by their generosity.

Some are parts:

Plant Training in Advanced Chemical Industries Limited (Part 1)

Plant Training in Advanced Chemical Industries Limited (Part 2)