Learn about the Standard Operating Procedures for the induction cap sealer machine, including their scope, responsibilities, precautions, procedures, and operation. 1.0 Scope: This SOP is applicable to setting and operating an induction cap sealer machine in the tablet department. 2.0 Responsibility: 2.1 Officer production is responsible for the implementation of this SOP2.2 Head production is responsible for ensuring the … Read more
After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery to the site. This inspection is referred to as the Factory Acceptance Test (FAT). The manufacturer of a machine will prepare the FAT protocol based on the Design Qualification, as per the built machine specification, … Read more
A Design Qualification comes to the role after the Design Specification as well as User requirements specification are finalized. Once URS is finalized follow the given specification requirement in the purchase order (PO). After checking it properly, the engineering, and production department will prepare the design qualification, which includes drawing, calculation, symbols, and other design … Read more
User requirement specification (URS) is a list of all the equipment-related requirements from the user, The list shall be prepared based on the types of equipment to be purchased. After the preparation of the list, the URS documents are sent to the manufacturer to get the required materials as per the given criteria. The user department … Read more
In the pharmaceutical industry, it’s essential to have sufficient lux or light intensity for carrying out work accurately. If the work area lacks proper illumination, it can lead to issues such as eye strain and fatigue, especially during detailed work. Excessive lighting is also unnecessary, as it may result in glare and dazzle. According to … Read more
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