Amster’s Process
&Technology
At Amster Microcell, our meticulous process begins with the selection of the best raw materials, rigorously tested to ensure premium quality. Automatic processes streamline production, while each step is meticulously maintained to uphold the highest standards. In rare cases of non-compliance, strict rejection protocols are enforced, guaranteeing that only top-tier pharmaceutical excipients reach our clients
Our state-of-the-art technology includes the best spray drier and advanced spray drying techniques, ensuring consistent particle size and superior quality. Contact-free packaging directly into LDPE liner bags prevents contamination, preserving product integrity. Continuous monitoring and cutting-edge machinery ensure that our processes are efficient and precise, delivering exceptional excipients to meet the exacting demands of the pharmaceutical industry.
Manufacturing Excellence
Batch-to-Batch Consistency
Ensuring batch-to-batch consistency is vital for maintaining product reliability. At Amster Microcell, every manufacturing step is meticulously documented, including raw material receipt and final product packaging. Statistical Process Control (SPC) is used to monitor and analyze process variations, helping to identify and address deviations promptly.
Regular internal audits are conducted to ensure strict adherence to Standard Operating Procedures (SOPs). This thorough approach guarantees that each batch of Microcrystalline Cellulose, Magnesium Stearate, and Croscarmellose Sodium meets the highest quality standards, fostering trust and reliability in our products.
Stability Testing
Stability testing is essential to ensure that products maintain their quality over time under various conditions. At Amster Microcell, we perform long-term stability studies by storing products under controlled environments to simulate extended storage conditions. This helps determine the product’s shelf life and effectiveness.
Accelerated stability testing is also conducted by exposing products to higher temperatures to speed up aging. Regular periodic testing at defined intervals ensures that any changes in attributes, such as potency or appearance, are detected, ensuring our products remain safe and effective throughout their shelf life.
Validated Cleaning Procedures
Validated cleaning procedures are critical for preventing cross-contamination and ensuring product purity. Amster Microcell develops and validates cleaning protocols for all equipment and facilities, using detailed Standard Operating Procedures (SOPs) that specify cleaning agents, methods, and frequencies.
Cleaning validation involves rigorous testing to confirm that residues are effectively removed, and procedures are periodically re-validated to maintain high cleanliness standards. This meticulous approach guarantees that every batch of our excipients is produced in a contaminant-free environment, ensuring the highest product quality.
Environmental Monitoring
Environmental monitoring is crucial to maintaining a clean and controlled manufacturing environment. At Amster Microcell, we conduct routine air and surface monitoring to detect microbial contamination and particulate matter. This includes sampling and testing using air samplers and surface swabs.
Temperature and humidity levels are continuously monitored to ensure they remain within specified ranges, preventing conditions that could affect product quality. Regular microbial testing further ensures that the manufacturing environment meets cleanliness standards, safeguarding the integrity of our products.
Customer-Specific Documentation
Customer-specific testing and documentation are integral to meeting unique client requirements and regulatory standards. Amster Microcell provides customized testing protocols based on individual customer needs, including additional tests for specific product attributes.
Each batch is accompanied by a detailed Certificate of Analysis (CoA), outlining test results, specifications, and compliance with quality standards. This thorough documentation ensures that products meet regulatory requirements and client expectations, reinforcing our commitment to quality and transparency.
Unmatched quality assurance standards
- Quality Assurance Standards
At Amster Microcell, our best-in-class spray dryer leverages advanced technology to ensure optimal performance and product quality. Featuring precise atomization and controlled drying parameters, our spray dryer achieves a consistent and uniform particle size distribution, which is crucial for enhancing the flow properties and compressibility of our excipients. The system’s precise control over inlet and outlet temperatures ensures the optimal moisture content, resulting in improved stability and dissolution rates.
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Additionally, the closed-loop design and contact-free environment during drying eliminate contamination risks, ensuring the highest purity and quality in our Microcrystalline Cellulose, Magnesium Stearate, and Croscarmellose Sodium products. This state-of-the-art equipment underscores our commitment to excellence and innovation in pharmaceutical excipient manufacturing.
- Commitment to the Environment and Our People
At Amster Microcell, we prioritize environmental sustainability and employee well-being. Our advanced water treatment systems reduce waste by recycling and purifying water used in our manufacturing processes. Regular motivational speeches and team-building activities foster a positive and productive workplace, ensuring a brighter future for all.