Color Coding, Purpose:
Color Coding, The purpose of this SOP is to define the color coding procedures of utility lines of XX Pharmaceuticals Ltd.
Color Coding, Scope:
This SOP covers the color coding procedure of utility lines in Production, PD, QC and Microbiology area of of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water
[][]CA: Compressed Air
[][]WFI: Water For Injection
[][]Elec: Electric line
[][]PoW: Potable water
[][]HW: Hot potable water
[][]NT: Nitrogen line
[][]PD: Product Development
[][]CWFI: Cold Water For Injection
Engineering (Validation) Department
[][]Preparing the SOP and revise it when necessary.
[][]Identification of the utility lines with the assistance of Engineering persons.
Engineering (Maintenance)
[][]To put on the labels on respective utility lines.
Respective department
[][]To ensure that the labels are properly maintained.
[][]To inform the engineering department if any label is torn or harmed by any means.
Head of Engineering
[][]To ensure that all the utility lines are properly labeled.
Head of Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Annexure:
N/A
Procedure:
Cleaning and Changing procedure:
[][]The list of utility lines which are to be marked is as follows:
[][]Purified water Potable water
[][]Cold Water For Injection
[][]Hot potable water
[][]Water for injection
[][]Compressed air Pure steam
[][]Nitrogen line
[][]Electric cable
The color coding procedure of each line is described below:
Purified water:
[][]All Purified Water lines must be tagged using an arrow head, Dark green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURIFIED WATER” must be written in the middle of the tag and the font would be Cambria, bold, and black color on white background as well. The sample of the tag is shown below:
Potable Water:
[][]All Potable Water lines must be tagged using an arrow head, light green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Hot Potable Water:
[][]All Hot Potable Water lines must be tagged using an arrow head, light green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “HOT POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold black color on white background as well.
Water For Injection:
[][]All WFI lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Compressed air:
[][]All Compressed Air lines must be tagged using an arrow head, dark blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “COMPRESSED AIR” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Pure Steam:
[][]All Pure Steam lines must be tagged using an arrow head, ash colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Nitrogen:
[][]All Nitrogen lines must be tagged using an arrow head, light blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “NITROGEN” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Electric line:
[][]All electric lines must be tagged using an arrow head, red colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “ELECTRIC CABLE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Cold Water For Injection:
[][]All Cold Water For Injection lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a light blue color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Chilled Water:
[][]All Chilled water lines must be tagged using an arrow head, blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “CHILLED WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
Pure Steam condensate:
[][]All Pure Steam condensate lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a yellow color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM CONDENSATE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.
[][]All the tags will be put on the utility lines by the respective engineer.
[][]The tag will be maintained properly by the respective departmental persons. If the tag is torn or harmed by any means, the engineering department must be informed to replace it.