PURIFIED WATER

PURIFIED WATER

WELDING AND CLEANING DETAILS

CERTIFICATION 

Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client.

10% of all orbital welded connections and 100% of all manually welded connections shall be inspected by certified person with endoscopic testing equipment. Pictures of the testing showing at least the starting point of the weld shall be included in the welding documentation for each tested weld.

PROCEDURE

  • Automatic orbital welding machine will be used to perform all welding of pipe.
  • No ferrous material, tools or equipment (carbon steel cutting tools) to be used in the fabrication or installation of system.

PURGING 

Welds are to be purged with 99.9% argon gas & inside of pipe shall have full line purge.

ALIGNMENT AND TACKING 

  • Accomplish tack welding in a manner that will not cause any deleterious effect on completed welds.
  • The tack welding will be as light as possible to reduce excessive heat that may cause structural changes to the granular composition of the system components.
  • No penetration to the inner surface of components.
  • Provision of maximum four tacks per joint.
  • Cracks or improper welds will be rejected.

DOCUMENTS AND LOG FOR EACH WELD WILL AS FOLLOWS: 

  • “As built drawing” with the weld number & details welds.(Manual, automatic)
  • Welding Parameters Protocol
  • Sample Approval
  • Name of Welder 

WELD DEFECTS 

Welds shall be rejected and removed including the heat-affected zone under the following conditions.

  • Crack pinhole present in welding
  • Non- uniform weld bead
  • Overlap at weld bead
  • Full penetration of the entire weld joint periphery: Required
  • Re-welding of defective weld is not permitted

SLOPE VERIFICATION 

The whole installation will be completely drainable. The slope of tubing should be greater than equal to 1:100 i.e. 1mm/100mm as per the Slope Verification Procedure.

HYDRO TEST OR PNEUMETIC TEST 

Hydro test or pneumatic test shall be followed by filling up the PW water or filter air from one end and close other end by using valve and pressure gauge assembly. Pressurize the system as per required pressure and maintain for 30 to 60 minutes and observed pressure gauge for pressure drop.

 PASSIVATION 

  • Passivation is a chemical treatment applied to stainless steel parts to provide resistance to oxidation, rusting and mild chemical attack. The Passivation process removes free iron (ferric material) from the surface of the parts that can be created during finishing operations such as milling, buffing, lapping, cutting, etc. These contaminants create potential sites for corrosion that result in premature deterioration of the component. The acids used for Passivation dissolve much of the alloyed iron on an atomic level right at the surface leaving a chromium and nickel-rich surface. It then creates the formation of a thin oxide film that protects the stainless steel from corrosion.
  • Cleaning medium shall be compatible with 0.4-micron surface finish. Cleaning is mandatory.
  • Passivation is mandatory for first time only. On line Passivation shall be carried out as per written pre-approved procedure and the same shall be documented.
  • All internal product contact surfaces are passivated in accordance with ASTM A967 standard and that the effectiveness of the passivation are measured.
  • Both Nitric and Citric Passivation treatments on Titanium and Stainless Steel alloys that adhere to QQ-P-35C, AMS-QQ-P35A, AMS 2700C, ASTM A 967-05 and ASTM A 380-06 standards. Passivation alone will not remove heavy adherent oxide films created from heat treatment, welding, hot-forming and other high-temperature operations. Therefore AST uses different types of pickling acids designed to remove these films prior to the Passivation of the parts. Our extensive experience with Passivation allows us to choose and match the appropriate Passivation and pickling procedure for your needs and specific stainless steel grades.

SANITIZATION 

Sanitization shall be done before start of system by circulating hot water at Temperature NLT 80°C to 85 °C for 30 mins.

IDENTIFICATION 

The whole system (Pump, Tank, sensors, valves, gauges and Instruments) shall be tagged. The tag no. will follow the numbers of the P & I Diagram.

VENT FILTER CARTRIDGE

Membrane MOC PTFE
O Ring MOC Silicon
Type Hydrophobic
Pore Size 0.2 micron

SPRAY BALL

Spray angle 360°
MOC SS 316L

UVD SYSTEM 

Wave length of UV lamp 254 nm (2537 Angstrom)

COMPOUND PRESSURE GAUGE

Filling liquids Glycerin
Nominal dial size 100 mm

PRESSURE GAUGE

Bourdon SS 316L
Filling liquids Glycerin

FLOW TRANSMITTER

Type Vortex type

DIAPHRAGM VALVE

Valve Type Two way manual diaphragm valve

SAMPLING VALVE

Valve Type Two way manual diaphragm valve
Body SS 316L

MANUAL ZERO DEAD LEG VALVE

Type Manual operated ‘J’ type zero dead leg valve
Body MOC SS 316L

ACTUATED DIAPHRAGM VALVE

Type of valve Pneumatically  actuated 2 way diaphragm valve
Body MOC SS316L

TC GASKET

MOC PTFE (Food Grade)

DOCUMENTATION

Following are the documents will be submitted with system supply:

  • P & ID
  • GA Drawing
  • Piping Drawing
  • Design Qualification
  • Installation and Operational Qualification
  • Test certificates of all bought out components
  • Manuals of all bought out items
  • Calibration certificates of all instruments
  • Welding Qualification documents
  • Control Sequence
  • Factory Acceptance Documents

INSTRUMENTS GOVERNING THE PRODUCT QUALITY & QUANTITY 

The instruments and indicators that shall be incorporated in the system are categorized as critical I. i.e. the instruments whose performance shall directly affect the quality attributes of the processed material, current calibration status shall be listed for these instruments only.  Monitor (M) i.e. the instrument whose performance failure would not affect product quality and which are used for process control. 

Sr. No Instruments/Indicators/Sensors Category
1. Pressure Gauge M
2. Capacitance type level transmitter C
3. Temperature sensor with transmitter C
4. Flow Transmitter C
5. TOC Analyzer C
6. Conductivity sensor & Transmitter C
7. UV System C

 

About Abha Maurya

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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