Assuming that a production batch of oral powder sachets was prepared using a dry mixing method. Post-preparation, a uniformity test for API was conducted, and the results were Satisfactory. Subsequently, the product was filled into sachets using a sachet filling machine. A content uniformity test was then performed, yielding non-conforming results. The root cause was…
In tableting the compaction force is a crucial parameter that is a major driver for the final product’s properties. But its influence varies across different characteristics: 1. Weight and Weight Uniformity: In general, the weight of tablets remains unchanged by compaction force, ensuring dosage consistency but on rotary tablet presses the weight uniformity sometimes…
This problem is most often caused by an error in the parameter or setting of the machine reasons for this problem. 1. Inappropriate pan speed, too high or too low. Solution: Work at a pan speed appropriate to the shape ot tablets. 2. The solution was not prepared and dissolved properly. Solution: Prepare…
Headspace oxygen levels in pharmaceutical products are critical to ensure product stability and safety. Regulatory guidelines provide specific limits and recommendations for controlling headspace oxygen to maintain product efficacy and quality. Here’s an overview based on industry standards and pharmacopeial guidelines: Importance of Controlling Headspace Oxygen: 1. Product Stability: Oxygen can degrade active pharmaceutical…
Black Spots Black-colored specks or dots on the tablet surface. Causes of Black Spots: Remedies for Black Spots: Inconsistent Thickness Variations in the tablet thickness within a batch or across different tablets. Causes of Inconsistent Thickness: Remedies for Inconsistent Thickness: Hardness Variation Inconsistency in tablet hardness across a batch or within…
Mottling Uneven distribution of color or pigmentation on the tablet surface. Causes of Mottling: Remedies for Mottling: Flashing It presents as a thin, unwanted edge around the perimeter of a tablet. Causes of Flashing: Remedies for Flashing: Chipping Breakage of tablet edges, resulting in small chips or fragments….
1. Capping Partial or complete separation of a tablet’s crown or upper portion from the main body. Causes of Capping: Remedies for Capping: 2. Lamination Tablets split into layers or laminates. Causes of Lamination: Remedies for Lamination: 3. Sticking It happens when the tablet material adheres to the punches and dies instead…
Pharmaceutical industries are involved in the manufacturing of medicinal products which are finally utilized by the patients so a great level of care & compliance is required at each level of manufacturing. What Is a Batch Manufacturing Record (BMR)? 1. A batch manufacturing record or BMR is a document that contains instructions on who…
The purchasing process is pivotal. It should be handled by individuals who have an in-depth understanding of both the products and the suppliers. Here are a 5 tips to keep your materials under control: Upon receipt of consignments, diligent checks are mandatory, including: – The package integrity to ascertain there is no damage…
