XCEL DC100: World's First Precision Weight Sorter for Implant Dosage Forms
CI Precision's XCEL DC100 is the only standard, automated weight sorter in the world designed specifically for high-precision weighing of implant dosage forms at various throughputs from R&D scale through to full production levels.
XCEL DC100 outperforms traditional checkweighers and laboratory balances for weight sorting subcutaneous implants.
Reduces human interaction
Lower QA/QC testing times
Designed to run in aseptic conditions
Wash in place.
High IP rating
Accurate and consistent batch-to-batch API dosage at all throughputs
Easy to access and error-free data in FDA-compliant templates
From initial R&D through to clinical trials and full-scale manufacturing, the XCEL DC100 is the only standard weight sorter solution that can meet the weight sorting requirements of each stage of drug development and production.
Designed to operate in aseptic environments and without any need for change parts, the XCEL DC100 minimizes the requirement for operator intervention. This eliminates error-prone and time-consuming tasks such as manual weighing, recording and equipment setup to ensure better batch consistency, improved quality and reduced resource demand. The XCEL DC100 is fully 21 CFR Part 11 and Annex 11 compliant. It has a high IP rating and is designed to be washed in place.
Accurate, reliable and compliance-ready, the XCEL DC100 ensures 100% weight inspection of every implant dosage form to minimise the need to rework batches and optimise workflows to realise greater lab and production efficiency.
Maximise Productivity with High- Precision Implant Weight Sorting
Solutions to Modern Industry Challenges
The introduction of stricter regulations and the constant drive to minimise costs are just some of the many challenges those in industry face.
From initial R&D through to clinical trials and full-scale manufacturing, each stage of the drug development and production chain faces unique day-to-day pressures that can actually be resolved through accurate weight sorting.
Automated, validated and versatile, the XCEL DC100 is the only ‘off-the-shelf’ weight sorter solution that can address many of the challenges in industry.
01. Solving the Challenges in R&D
With boosted investment in drug-eluting implant research and development, researchers are under increasing pressure to accelerate formulation development to bring much-needed therapies to patients sooner. And with drug-development timelines and costs continuing to rise, researchers need to optimise their processes to develop formulations more quickly and reduce costs without compromising on quality or compliance.
Using automated, high-precision weight sorters, technicians can gain greater confidence in their formulations and rely on better, more accurate data to accelerate decision-making.
Here are some ways XCEL DC100 addresses the challenges in R&D:
For Lab Managers who need to:
The XCEL DC100 solution
Maximize productivity with limited resources
Automated, 100% weight sorting enables lab staff to focus on higher-value tasks
Maintain data integrity
Pre-prepared, 21 CFR Part 11 compliant report templates allow for quick, easy and secure record-keeping
Reduce manual tasks and human error
Automated and accurate readings are taken continuously
Avoid cross contamination and maintain quality irrespective of environmental factors
Designed to operate in aseptic conditions with built-in static elimination to prevent static-induced weighing variability
02. Addressing the Challenges in Clinical Trials
Clinical trials are a crucial part of the drug development process and represent a significant milestone when they are completed successfully. Accurate weight sorting is essential to deliver duty of care and ensure consistent and accurate trial results.
With high-precision and automated implant weight sorting, weight-defective implants are rejected well before they can cause delays, invalidate trials or result in product recalls. Precision weighing ensures every implant dose is consistent, which helps to guarantee the validity of the trial results and the success of the clinical trial.
The XCEL DC100 offers excellent solutions to the issues faced in clinical trials:
For Clinical Trial managers who need to:
The XCEL DC100 solution
Keep time to market as short as possible
Total confidence in trial product quality due to 100% weight checking
Comply with multiple and varied regulatory frameworks
100% weight inspection enables a coordinated quality and process control programme for verified trial compliance and data reliability
Control trial budgets
Data is collected at a fraction of the cost of manual weighing and recording
Maintain absolute consistency of API quantity to guarantee trial validity
Quick, high accuracy, weight sorting based on expected API content safeguards trial investment
Ensure uninterrupted supply of product to trial patients
High accuracy weight sorting prevents weight defective implant related delays
03. Tackling the Challenges in Manufacturing
Large manufacturers require high precision accuracy and reliable weight sorting to maintain maximum throughput. Small contract manufacturers, on the other hand, may be servicing multiple clients and require the flexibility to enable quick changeovers to increase output and product quality.
Automation is an excellent way to optimise production lines to keep throughput levels high as well as maintain reliable, safe and compliant operations.
Here are some ways the XCEL DC100 can help manufacturers:
For Production Managers who need to:
The XCEL DC100 solution
Meet quotas, schedules and margins
Benefit from outstanding accuracy and reliability matched with high flexibility
Comply with regulatory requirements and maintain certification
100% check weighing shows commitment to GMP
Optimize processes and achieve consistent performance
Minimized downtime - no costly change parts required
Manage product handling for environmental factors
Designed for use in extreme environments and for products that require extra special handling
Deploy available workforce resources for maximum productivity and efficiency
Maximize performance with tighter production tolerances, lower waste, and higher yields
Collect and analyze large amounts of data
Easy access to QC data with automated data capture, timestamping and tamperproof record-keeping
04. Approaching the Challenges in QA/QC
In an ever-evolving industry, the QA team must juggle many aspects of manufacturing in order for the business to stay competitive. The QA team must keep on top of quality, costs and reliability while remaining compliant.
For the QA team to achieve this successfully, quality assurance must become a proactive process to ensure that products are manufactured to specific standards and that processes are in place to improve results and eliminate errors.
Accurate and automated weight sorting eliminates many of the time-consuming and error-prone tasks that are associated with manual weighing, making it much easier to meet the stricter quality assurance requirements of implant dosage forms.
The XCEL DC100 helps the QA team maintain optimal and compliant operations:
For QA/QC Managers who need to:
The XCEL DC100 solution
Reduce admin and maximize the value provided to customers
Easier record keeping with automated data collection and 21 CFR Part 11 compliant templates
Reduce cycle times for issue resolution and frequency of deviations
Fast sorting of weight defective products
Avoid bottlenecks in testing
Greater confidence to release 100% weight-checked production batches
Optimise operations to meet regulatory requirements
Easy access to statistical and QC data for process optimisations