Académique Documents
Professionnel Documents
Culture Documents
Housekeeping in General area, Tablet production area, Manufacturing area, Compression/packaging area, Oral liquid production area, Ointment productio
area, Sterile product production area (100 class), Frequency of cleaning of pharmaceuticals.
1.INTRODUCTION:
An important factor of quality assurance is good housekeeping. Manufacturing and other operational areas need regular cleaning and disinfection, in
order to remove spillage powders, dust and dirt. Cleaning ensures avoidance ofcross contaminationand to maintain working environment tidy and
safe.
2.OBJECTIVES:
to facilitate smooth movement of goods and personnel
to prevent contamination of stored material
to improve aesthetics
to avoid mix-ups
to avoid damage to the goods
3.EQUIPMENT NEEDED:
sponge mop
rubber mop
broom
dustbin
antiseptics & disinfectant
4.PROCEDURE:
I General area:
All utensils used in manufacturing area such as scoops, sieves and vessels after use must be cleaned by appropriate cleaning solution.
After cleaning with solution all equipment rinsed with water, dried and stored covered with polythene bag.
All area must be cleaned with vacuum cleaner to remove the dust and powder in floors, walls, ceilings and ventilators.
floor is firstly cleaned with normal water as perSOP of cleaning.
after clean by normal water use detergent solution.
The floor must be mopped with 0.1% Teepol and water.
Oil spillage if any, is wiped off immediately to prevent area contamination with 70% IPA.
corridor and other operating areas are swept with nylon broom
wet cleaning is done immediately after brooming
II.Tablet production area:
i.Manufacturing area:
clean the powder spillage in compounding area with wet floor mops only
after the process work is completed and also at the end of the day, clean floors with disinfectant solution as per the cycle
Use 1% v/v Lysol solution as disinfectant to clean the floor.
Water spillage should be cleaned immediately by rubber mop.
Rubbers stoppers and glass pieces if any are collected in a dustbin.
At the end of the day, floor is cleaned with 0.1% v/v Teepol solution and 1% v/v Lysol solution as disinfectant.
All glass panes in the non sterile manufacturing area are cleaned using 70% IPA.
CAUTION:
Do not use brooms to clean compounding area.
Cotton mop should not be used to clean the preparation area because it may leaves behind cotton fibers.
VI.Packaging area:
Ensure that proper line clearance before starting sterile/non sterile packaging for the next product/batch.
All packaging materials including overprinted materials should be received in full quantity as per indent before starting packaging operation.
All the packaging materials and product to be packed are arranged in such a way that the product identification is easy.
Packing materials as well as the bulk tablets should be stored on the plastic pallets.
With the help of vacuum cleaner, all the dust on the floor and in the wall cleaned periodically.
Ensure that all the worker in packing department wear clean uniforms.
Operators who run machine must use masks and hand gloves.
Empty the dustbin regularly.
Spillage of any liquid on the floor should be immediately cleaned and floor should be wiped dry.
5.CLEANING AGENT USED:
I.In non sterile manufacturing area:
c) Alcohol ethoxylate
Lysol Cresol in soap 1.0%
Disinfectant Savlon a) Chlorhexidine gluconate 1.0%
b) Cetrimide
c) Isopropyl alcohol
Isopropanol Isopropyl alcohol 70%
b) Cetrimide
c) Isopropyl alcohol
Isopropanol Isopropyl alcohol 70%
8.RECORDS NEEDED:
I.Liquid area
Equipment cleaning records
Submitted by:
MD. ABDUL BAKE*1, MD. ZUBAIR KHALID LABU2
Address:
*1 Product Development Officer, Gonoshasthaya Pharmaceuticals Limited, Dhaka, Bangladesh
2 Head of the Pharmacy Department, World University of Bangladesh, Bangladesh.
Email: Md. Abdul Bake* - abdul.bake@yahoo.com
Md. Zubair Khalid Labu - zubairlabu@yahoo.com
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical
blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Need Help: Ask Question
Offline