Pellets in pharma are small, free-flowing spherical or semi-spherical drug-containing units used mainly in capsule filling or multiparticulate tablet systems. They help improve drug release control, content uniformity, taste masking, and reduce gastrointestinal irritation. Pellets can be prepared by methods…
A Packing SOP in pharma defines the standard method for packing finished products correctly and safely. It covers line clearance, area and equipment cleaning, issuance and verification of packaging materials, machine setting, coding checks, in-process checks, rejection handling, reconciliation, and…
Benzyl alcohol (BA) is used in injectable products mainly as an antimicrobial preservative (especially in multi-dose containers) and sometimes as a co-solvent to help dissolve an API. Here’s what matters most when you’re considering it in an injectable formulation. Where…
1. Pre-entry checks (outside change room) Before even touching the change room door: 2. Change Room – Stage 1 (Black to Grey) Purpose: Remove gross contamination from outside environment. 3. Handwashing & Hand Disinfection Performed before putting on sterile gloves.…
Operational Qualification (OQ) for Vibro Sifter [PICTORIAL] Check that the Vibro sifter operates correctly without product under defined operating ranges. Typical OQ tests & checks: Operational Qualification Acceptance:
Typical Installation Qualification for Vibro Sifter [Pictorial] checks: Installation Qualification for Vibro Sifter (Acceptance Criteria):All items verified and found compliant; deviations evaluated and closed.
In pharma, disinfectant efficacy validation is the documented proof that your chosen disinfectants, at their actual in-use dilution and contact time, can control the real microflora on the real surfaces in your facility, as part of your contamination control strategy.…
Fogging in pharma is a whole-room disinfection method where a disinfectant is aerosolized into a fine mist (fog) to cover all exposed surfaces and the air in controlled areas like cleanrooms and sterile production zones. It is an additional step,…