Utilities Description Diw Wfi Steam and Compressed

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11.1 Utilities Description

The major utilities involved in the routine operation of a plant, which are used to a great extent in the cleaning of products, are as follows.

11.1.1 Water System

ABC Pharmaceutical Company manufactures two levels of water quality: water for injection (WFI) for sterile products and purified water for other dosage forms.

City water is supplied from a municipality source and enters the ABC Pharmaceutical Company building. After passing through a backflow preventer, it is diverted to general plant use or to the purified water pretreatment system, which includes a reverse osmosis (RO) system. This system supplies purified deionized water (DIW) to the pure steam generator, the ampoule/vial washer, cleaning use points, and the distillation unit used to produce WFI.

11.1.2 WFI System

The condensate of the heated vapor (free distillate) is collected in the condenser, where the vapor is cooled and condensed by incoming cooling water. WFI is collected in the main storage tank (6000-L capacity) from where two loops, one for the CIP of the freeze dryer and the other for distribution in building C, start.

Temperature indicators are used to monitor the temperature continuously. The temperature requirement is >85°C for the WFI tank and >80°C for the water distribution system. Conductivity and temperature at the return of the loop are monitored and registered on control panels. Sampling points are available near each main point of use.

Weekly chemical and physical monitoring of WFI from commodity washing and solution preparation is performed. The same two points are also used for daily microbiological monitoring along with the parenteral area WFI inlet.

11.1.3 Purified Water System

The GMP design of the water treatment plant aims to produce purified water from city water. The purified water quality complies with USP pharmacopeia.

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The system consists of

1. Chlorination dosing set

2. Heat exchanger for raw water-cooling

3. Sand filter

4. Carbon filter

5. Antiscalant dosing set

7. RO station

8. Potable water tank

9. Deionizer

10. UV sterilizer

11. Purified water tank

Purified water circulates in a stainless steel loop supplying purified water to the required use points. The water treatment plant is fully automatic and is controlled through a control room in the utilities area.

11.1.4 Process Chilled Water System

Chilled water is an important utility used for cooling purposes.

11.1.5 Steam System

Clean steam is used for all equipment, which comes into contact with containers, solution, or closures prior to product assembly. A generator fed by DIW produces pure steam. The steam generator is located on the first floor of the main building of ABC Pharmaceutical Company, from where the loop starts to different use points. Steam traps are installed to collect condensate when necessary. The quality of pure steam condensate is the same as established for WFI, USP. The quality of pure steam is monitored through a quality analyzer system that measures the conductivity of condensed pure steam.

Industrial steam is produced by two boilers, each with a capacity of 5000 kg/h. The system is fully automatic with a control and monitoring system. The steam is used for

• Heating during product processing

• Sanitization of the DI loop

• Sterilization of Al(OH)3 vessels

11.1.6 Compressed Air

Oil-free compressed air is produced in rotary screw compressors. It is stored in a stainless steel receiver and then passes through a 1-| m filter for particle removal and through two

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air dryers to ensure complete removal of moisture traces. It is delivered to the plant via a stainless steel loop that supplies all use points and is equipped with a filter and regulator.

Use points are defined to be critical, where compressed air quality is considered of medical grade, USP.

i. Vials-washing machine ii. Sterilization autoclave iii. Liquid-filling lines for bottles air blowing

11.1.7 Compressed Air (Solid and Liquid Products)

Oil-free compressed air is produced in two identical rotary screw compressors (model and make), each with a capacity of 15 m3/min. Compressed air is stored in a stainless steel 316-L receiver (4-m3 capacity) and then passes through a 1-|im filter for particle removal and through two air dryers to ensure complete removal of moisture traces.

The oil-free compressed air is delivered to the plant via a stainless steel 316-L loop that supplies all use points and has a filter and a regulator.

The system is monitored through a remote monitoring system (model and make) that senses the operation of the compressors and displays this in the control room.

11.1.8 Nitrogen System

Nitrogen is used for

• Purging during product preparation

• Purging during filtering of oxygen-sensitive products

• Vacuum break after powder transfer

• Weighing of oxygen-sensitive active materials

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