These days, choosing the right material for constructing manufacturing equipment parts is an important aspect. Manufacturing equipment is usually made of stainless steel, with various alloys in SS such as 304, 316, and 316L. These alloys are widely used and valuable. Type 304 is a commonly used alloy in the group of steel known as … Read more
Before starting to pack any product, the Production officer and Q.A. officer should check the area based on the line clearance checklist mentioned in the BMR/BPR records. While conducting line clearance, make sure to follow all points to ensure product quality and prevent contamination, mix-up, and cross-contamination. Line Clearance Checklist point for Primary Area: Related … Read more
Autoclave validation is required to get effective Sterilization to ensure good product quality and also sterility of glassware and media used for analysis is very important for product manufacturing. Ineffective autoclave validation may cause deviation in sterility and it may lead to a false result. So data loggers play a very important role in recording the … Read more
Learn about the Standard operating procedure for “Entry and Exit Procedure in Pharmacautical” along with Purpose, Scope, Responsibility, Instruction, Procedure, Entry procedure for employees, Exit procedure for the employees, and Entry and Exit procedure for visitors. 1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals. 2.0 scope: 2.1 This SOP applies to all personnel, … Read more
In pharmaceutical industries AHU and HVAC play an essential role in controlling microorganism-free environments by supplying fresh air. The quality of pharmaceutical products is dependent on hygiene within the industry. Preventing the spread of microorganisms through the air is highly significant. Whether it’s during laboratory development or manufacturing activities, maintaining a clean and suitable room atmosphere is … Read more
A Rapid mixture granulator (RMG) is used in mixing, agitation, and shear mixing (to break internal molecular force). It is used in pharmaceuticals to make granules. The components of the RMG (impeller and chopper) are highly responsible for the wet granulation process. Components of RMG: Rapid mixture granulator components are as follows: The impeller and chopper are responsible … Read more
Multimill is used widely in pharmaceuticals (granulation section), cosmetics, chemicals, and bulk drugs for cutting granules into small particle sizes by using cutting, Pulverization, and hammering mechanisms. Components of multi-mill: 1. Hopper inlet The hopper is used to feed products to the mill. 2. Milling chamber The milling chamber contains a screen to reduce particle … Read more
1.0 Purpose: To lay down the standard operating procedures for the Collection and Disposal of product waste.2.0 Scope: This scope is applicable to all the product waste generated during the following activities. 3.0 Responsibility:3.1 Officer concerned department is responsible for the Product Waste; Collection and Disposal.3.2 All concerned heads of the department and head of Quality Assurance are … Read more
A colloidal mill is used to break down a mixture that contains Suspended solid particles to make a homogeneous mixture. So it is used in a wide range of pharmaceuticals and other industries to make a suspension. Working Principle of Colloidal Mill: The colloidal mill works on Shearing by using a rotor/ stator. By using shearing force its … Read more
Disintegration test apparatus is widely used in pharmaceuticals to identify the disintegration properties of various types of tablets and capsules. The DT apparatus decides whether or not tablets or capsules disintegrate within a recommended time once placed in a liquid medium. What are Disintegration and Principle Disintegration is defined as that state in which no residue of the … Read more
The coating on tablets helps withstand the gastric environment and also has many advantages like masking the odor, color, and taste of a drug along with physical and chemical protection. Sometimes tablet’s quality may be improper if, the proper method and technique are not followed during the coating process. So to avoid these problems, we … Read more
Learn about Standard operating procedures on Leak Test Apparatus including Purpose, Scope, Responsibility, Procedure, How to perform Leak test for blister and containers and aluminum triplex, limit, Action on Failure of leak test for blister or strips, Frequency, Challenge test, Cleaning and calibration of leak test apparatus. 1.0 Purpose: To let down the standard operating … Read more
Validation of the water system is important in the pharmaceutical industry. Water is extensively used in the manufacturing process at various stages. Throughout manufacturing, water is consistently generated and distributed, making it unusable to test and analyze every quantity used in production. To ensure consistent quality standards, it’s essential to validate the treatment, generation, storage, … Read more
The pharmaceutical industry generates lots of wastewater during the production or formulation of medicines. So it is very important to treats this wastewater by using various techniques. Water purification technology is used to eliminate solids from liquids. The impure solids can be coarse, suspended, colloidal, and dissolved. In the purification process, they need to be … Read more
The Drugs and Cosmetics Rules 1945 is the set of rules under the Rules of Drugs and Cosmetic Act 1940, which keep the provisions for the classification of medicine. Below are the given schedules and Also described guidelines for the sales, storage, display, and prescription of drugs in each schedule. List of Drug and Cosmetic Schedules: Schedule … Read more
Learn about Standard operating procedures for Camera Vision Systems and Pinhole detector including Aim, Purpose, Responsibility, Precautions, Procedure, Frequency, and Annexures. Aim: Standard operating procedure for camera vision systems in Pharmaceutical Purpose: To lay down the procedure for setting, operation, and in-process check for the camera vision system and pinhole detector. Scope: This standard operating procedure is applicable to carry out … Read more