PHARMA KING ACE

 In pharmaceutical manufacturing, particularly in the **Rapid Mixer Granulator (RMG)**, several **Critical Process Parameters (CPPs)** must be closely controlled to ensure the granulation process is consistent, reproducible, and results in a high-quality product. These parameters directly influence the granule properties such as size, density, and uniformity, which in turn affect the drug's dissolution, bioavailability, and stability. ### Key Critical Process Parameters (CPPs) in RMG: 1. **Impeller Speed (Mixing Speed)**:    - **Impact**: The impeller speed determines the shear and intensity of the mixing action. Too low a speed may lead to inadequate mixing, while too high can result in excessive shearing and over-granulation, which can cause poor flowability and excessive fines.    - **Control**: Typically adjusted based on the formulation requirements, with optimal speeds being set for different stages of granulation. 2. **Chopper Speed**:    - **Im...

HVAC is an essential aspect in pharmaceutical industry as factors like temperature, relative humidity and ventilation have a direct impact on the quality of the pharmaceutical product. The designing of the HVAC should be sorted out while design concept of facility is in progress as it is linked to the architectural layouts like air locks, doorways and lobbies. Once the HVAC system is properly designed and installed it not only helps to create the required room pressure differential cascades but also prevents the cross contamination. Basically an HVAC system works by transferring the heat and moisture into and out of the air and controls the level of the air pollutant either by removing them or diluting them to a particular level. TECHNOLOGY OVERVIEW: HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same. LAYOUT OF A TYPICAL BASIC HVAC SYSTEM HEATING SYSTEM: The heat source is either a furnace or ...

TYPES OF GRANULATION Granulation can be achieved by three method as follows :- 1. Direct compression          Crystalline substance like sodium chloride, sodium bromide may be compressed directly. The vast majority of medicinal agents are rarely so easy to tablet, direct compression material should posses good flow and compresibility and must be inert, tasteless, able to disintegrate and inexpensive. Method (Drug + filler + disintegrant + lubricant + glidant ) all are blend directly after sifting through Viber sifter and compressed 2. Dry Granulation    It is used in situations where effective dose of a drug is too high for direct compaction and the drug is sensitive to heat, moisture, or both which preclude wet granulation. This is also called slugging method. Method A.      (Drug + filler + lubricant) All are.       blend then precompression done and     after that   comminu...

Formulation and manufacturing of Lipstick Lipstick:- Lipstick  is a cosmetic product  containing pigments , oils , waxes , and emollients  that apply color, texture, and protection to the lips . Lipstick Raw Materials  Before making lipstick, ingredients must be chosen. The primary ingredients of every lipstick are waxes, oils, and pigments, but many other substances can be introduced into the mix that will enhance certain parts of the final product and add it some specific new features such as fragrance, longevity and gloss. The wax used usually involves some combination of three types : beeswax, candelilla wax or the more expensive carnauba. Wax enables the mixture to be formed into the easily recognized shape of the cosmetic. Oils such as mineral, caster, lanolin, or vegetable are added to the wax. Some of the most common secondary ingredients are preservatives (to ensure longer shelf life), alcohol (solvent for other substances), fragrance (oils and waxe...

There are basically two types of water preparation in pharmaceuticals.Water for Injection (WFI) preparation process and Purified Water preparation process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection (WFI) system in pharmaceuticals has stricter bacterial control standards than purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection (WFI) preparation process in pharmaceuticals must include distillation or double pass reverse osmosis techniques. Water for Injection (WFI) preparation process in pharmaceuticals systems, involves several steps and processes this includes; dechlorination, ion reduction, bacterial control, and removal of specific impurities. Dechlorination: This refers to the removal of chlorine from the water. There are several ways of dechlorination.This include injection of a reducing agent lik...

Disintegration Time:- Uncoated Tablet NMT 15 min, in water with Disc 37 0 C ± 2 0 C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab , and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Soluble Within 3 min in water at 25 0 C ± 1 0 C ( IP ) & 15 – 25 0 C ( BP ) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 30 0 C ( IP ) & 5  min in 200 ml water at 15-25 0 C ( BP ) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 37 0 C ± 2 0 C. If 1 or 2 tabs fail, repeat for 12 tabs. Click to Buy Here

Weight Variation Limits:- 1) For Tablets  IP/BP.                           Limit.                          USP 80 mg or less.             10%                     130mg or less  80 mg to 250mg.       7.5%               130mg to 324mg 250mg or more.          5%               More than 324mg 2) For Capsule:- IP Limit Less than 300mg 10% 300mg or More 7.5%

ABBREVIATION:  Abbreviation is an shortened form of an word, the most commonly used abbreviations in pharmaceutical company                                                 AADA: Abbreviated antibiotic drug application ADE: Adverse drug event ADME: Absorption, distribution, metabolism, and excretion AHU: Air Handling Unit ANDA: Abbreviated new drug application ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) AP: Applicants Part (of EDMF) API: Active pharmaceutical ingredient APR: Annual product review (APQR – Annual product quality       ...