Addressing Challenges in Leak Testing for Cold Chain and Terminally Sterilised Products
Leak testing for cold chain and terminally sterilised products presents unique challenges due to factors such as condensation and entrapped moisture, which can compromise the accuracy of traditional detection methods. Challenges Posed by Condensation and Entrapped Moisture Cold chain and terminally sterilized products are particularly susceptible to moisture-related issues during leak testing: 1. Condensation in […]
Ink Printing/Laser marking on Solid Dosage Drug Products-Which is better
Applying identification on solid dosage drug products can be necessary from the point of regulatory compliance, patient safety and brand protection. Identification marking on tablets, capsules and softgels prevents medication errors, ensures traceability and protects against counterfeiting. The choice of marking technology often causes confusion. With large volumes and high speed requirements an added factor […]
The Impact of Physical Attributes of Tablets on Tablet Imprinting with Ink
Tablet imprinting is sometimes necessary for ensuring precise identification, brand differentiation and regulatory compliance. However a tablet’s shape, dimensions and surface lubricity significantly impacts the ability to effectively imprint ink logos on them. In practice it is found that many tablets do not lend themselves well to imprinting of logos at high speeds and often […]
The Challenge of Testing Sterile Containers Sealed Under Vacuum for The Presence of Vacuum-Annex 1 compliance
The revised Annex 1 guideline, released in August 2022, includes specific requirements related to container closure integrity. Clause 8.24 states: “Containers sealed under vacuum should be tested for maintenance of vacuum after an appropriate pre-determined period prior to certification/release and during shelf life.” While testing for presence of headspace oxygen is more commonly known and […]
FAQs from PMEC 2024
At the recently concluded PMEC 2024, our booth attracted significant visitor interest by showcasing innovative solutions addressing Annex 1 compliance challenges. The frequently discussed points: 1. Testing for the presence of vacuum in containers sealed under vacuum 2. Cleaning tools and processes to address residues of disinfectants 3. Establishing a validated life cycle for secondary […]
Navigating the Complexity of Lyophilization Cycle for Sensitive Drug Formulations
Image Credits: DALL.E Fill-finish and lyophilization are essential processes in the pharmaceutical industry, particularly for protecting sensitive drug formulations. Fill-finish occurs before lyophilization during which the drug formulation is precisely filled into vials or other primary packaging to ensure dosage accuracy and prevent contamination. Following the fill-finish process, lyophilization significantly improves product stability by removing moisture, prolonging shelf life, […]
Why It Is Difficult To Find the Perfect Clean Room Wipe And How MiraWIPE Scores high…Here’s A Simple Analysis
In critical fill-finish sterile areas, even the smallest particles and fibers can cause significant contamination issues endangering the finished injectable product for usage, leading to high rejection rates and increased costs. Choosing the right wipe thus becomes critical to ensure surfaces remain uncontaminated and finished products are not compromised. Which is why, Clean Room wipes […]
Eliminating Residual Drug Contaminants: How the Sahara+ System Maintains Clean Surfaces while minimizing risk of cross over contamination in Oral and Solid Dosage Manufacturing
Maintaining an immaculate environment is essential in oral and solid dosage manufacturing. However, even the most stringent cleaning protocols can struggle against stubborn drug residues deeply entrenched in the grain of the equipment surfaces. Traditional methods often resort to harsh chemicals or abrasive techniques, risking damage to delicate equipment and compromising product integrity. Introducing the […]
Mastering Corrosion: The Role of Diamond ScrubPADS and PneuSCRUB in Stainless Steel Equipment Restoration for Oral and Solid Dosage Manufacturing
Image Credit: DALL.E In the oral and solid dosage manufacturing, maintaining impeccable facility standards is paramount. However, even with meticulous cleaning protocols, the persistent challenge of corrosion can occasionally emerge, threatening the integrity of stainless steel equipment. Corrosion not only compromises visual aesthetics but also creates potential havens for contaminants, thereby jeopardizing both product quality […]
4 Key Insights on Facility Maintenance and Cleaning from the PDA Conference 2024, Hyderabad
Image Credit: DALL.E In our previous blog post, we elaborated on some of the frequently asked questions (FAQs) on Leak Testing/Headspace Analysis that our team answered at the recently held PDA Conference in Hyderabad. In this blog post, let’s uncover some key questions on facility maintenance and cleaning that we were asked by leading Injectable/OSD […]