Equipment Description

Your Company's L

Your Company's L

Your Company's N

Your Company's N

In this chapter, a detailed list of equipment used in ABC Pharmaceutical Company is presented in the tables below. These equipments are divided into categories for solid, liquid, and injectable manufacturing areas.

Equipment found in these areas must meet the specific acceptance criteria to be considered qualified/validated.

This would be the first step in identifying the worst-case product for cleaning validation. The basic idea would be to develop, based on the equipment and products list, the equipment train for each product type from different dosage forms. This practice will make the task of identifying the worst-case product much easier and simpler.

9.1 Solid Dosage Manufacturing 9.1.1 Equipment Description

Equipment Location/Room No.

Activity

Machine Name and Model

Line 1—tablets/capsules blistering ABC Pac system, tablet hopper tablet channel Line 2—tablets/capsules blistering ABC Pac system II, blistering machine

Alu-Alu blister Tablet counting

Weighing booth 1 Weighing booth 2 Preparation room 1 Preparation room 2 Granulation room 1 Granulation room 2

Striping machine Container-packing machine Scoops, spatula Scoops, spatula Mixers

Solution preparation vessels Granulator, fluid bed dryers Granulator and vacuum dryer, weighing stations

Your Company's Logo

Your Company's Logo

Your Company's Name

Model and Serial/

Room No.

Activity

Machine Name

Asset No.

1

Blending

Tumbler blender 2000 L

Model of the machine

2

Tablet compression I

Tablet press with fully computerized incheck master and dedusting system

process

Model of the machine

3

Bulk loading room I

Bin-emptying station

Model of the machine

Tablet compression II

Tablet press with fully computerized incheck master and dedusting system

process

4

Bulk loading

Bin-emptying station

Model of the machine

Tablet compression III

Tablet press with fully computerized incheck master and dedusting system

process

5

Bulk loading

Bin-emptying station

Model of the machine

6

Tablet compression IV

Tablet press with fully computerized incheck master and dedusting system

process

Model of the machine

7

Bulk loading room IV

Bin-emptying station

Model of the machine

8

Tablet compression V

Fully computerized with in-process check master

Model of the machine

9

Bulk loading room V Capsules filling I

Bin-emptying station Capsule-filling machine

Model of the machine

10

Bulk loading room VI Capsules filling II

Bin-emptying station Capsule-filling machine

Model of the machine

11

Bulk loading room VII

Bin-emptying station

Model of the machine

12

Sugar coating

Sugar-coating pan with suspension Cota

Sugar cota 60-130 kg

13

Film coating I

Film-coating machine with cotab

Cota 1

14

Film coating II

Film-coating machine with cotab

Cota 2

15

Film coating III

Film-coating machine with cotab

Cota 3

15

Loading I

Tablet-transfer system

T-Mail

16

Loading II

Tablet-transfer system

Model of the machine

17

Loading III

Tablet-transfer system

Model of the machine

18

Powder filling

Powder for suspension filling

Model of the machine

19

Loading V

Bin-emptying station

Model of the machine

20

Washing area

Bin-washing station

Model of the machine

21

Powder bins

Powder bins 600 L Powder bins 1000 L Powder bins 2000 L

Model of the machine Model of the machine Model of the machine

22

Tablet bins

Tablet bins 300 L Tablet bins 500 L

Model of the machine Model of the machine

23

Sieves

Model of the machine

24

Tablet deduster

Model of the machine

25

Piping/tubing/hoses

Model of the machine

26

Homogenizer

Model of the machine

27

Sorting machine

Model of the machine

28

Deblistering machine

Model of the machine

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

Room No.

Activity

Machine Name

Model and Serial/Asset No.

Room No.

Activity

Machine Name

Model and Serial/Asset No.

21

Powder filling

Powder-filling machine

Model of the machine

Powder filling

Powder-capping machine

Model of the machine

22

Capsule filling

Capsule-filling machine

Model of the machine

23

Milling

AAA mill

Model of the machine

Milling

AAA sifter

Model of the machine

24

Washing

Bin-weighing station

Model of the machine

Blending

AAA tumbler

Model of the machine

Blending

AAA bins

Model of the machine

25

Dispensing

Weighing cabinet (balance)

Model of the machine

26

Washing

Automatic washing station

Model of the machine

9.2 Sterile

9.2.1 Equipment Description (Injectables)

Room No.

Activity

Equipment's Description

Model and Serial/Asset No.

S1

Filling and closing

Filling and closing machine for syringes

Model of the machine

S2

Preparation

300 L manufacturing vessel

Model of the machine

Preparation

300 L mobile vessel

Model of the machine

Preparation

Mobile vessel

Model of the machine

Preparation

Preparation reactor

Model of the machine

Preparation

Formulation tank

Model of the machine

Preparation

Mobile holding tank

Model of the machine

Preparation

Formulation tank

Model of the machine

S3

Filling

Tank

Model of the machine

S4

Freeze drying

Freeze dryer

Model of the machine

S5

Filling and closing

Automatic vials filling and closing machine

Model of the machine

S6

Filling and closing

Ampoules filling and closing machine

Model of the machine

S6

Filtration

Filtration accessories, hoses

Model of the machine

Dispensing

Material dispensing cabinet

Model of the machine

Filtration

Filtration assembly

Model of the machine

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

9.3 Liquid Manufacturing

9.3.1 Equipment Description (Soft Product)

Vessel No.

Activity

Vessel's Description

Capacity/Make/Model

Raw material storage

Raw Material Silos L1 L2 L3 L4 L5 L6 L7 L8 L9 L10

Preparation Vessels

L11 Preparation

Manufacturing Vessels

Manufacturing

Sorbitol Sorbitol

Propylene glycol Propylene glycol Glycerin Glycerin

Syrup sugar vessel Syrup sugar vessel Al(OH)3 Al(OH)3

Sugar solution Gel dilution Intermediate solution preparation Mixer SS bins

Syrup preparation Syrup preparation Syrup preparation Suspension preparation Suspension preparation Oral drops preparation Manufacturing vessel Melting vessel Sterile cream manufacturing machine

XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make

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XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make XXX L/make

XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC XYZ company/model ABC

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

Vessel No.

Activity

Vessel's Description Capacity (L)

Holding Tanks

G-01

Syrup/suspension/

Syrup storage vessel

7500

G-02

drops holding

Syrup storage vessel

7500

G-0S

Syrup storage vessel

7500

G-04

Syrup storage vessel

7500

G-05

Syrup storage vessel

7500

G-06

Syrup storage vessel

7500

G-07

Suspension storage vessel

5000

G-08

Suspension storage vessel

10,000

G-09

Suspension storage vessel

10,000

G-10

Oral drops storage vessel

2500

G-11

Oral drops storage vessel

9.4.1 Equipment Description (Soft Product)

Filling Lines Description of Equipments

Filling line 1

Filling tank

Hoses/tubing

Nozzle

Filling line 2

Filling tank

Hoses/tubing

Nozzle

Filling line 3

Filling tank

Hoses/tubing

Nozzle

Filling line 4

Filling tank

Hoses/tubing

Nozzle

Filling line 5

Filling tank

Hoses/tubing

Nozzle

Suppository filling line 6

Filling tank

Hoses/tubing

Nozzle

Cream/ointment filling line 7

Filling tank

Hoses/tubing

Nozzle

Sterile cream filling line

Filling tank

Hoses/tubing

Nozzle

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