Precision Weight Sorter for Implant Dosage Forms

The 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.

Delivering outstanding accuracy and reliability, the XCEL DC100 can provide 100% weight inspection of every implant dosage form, sorting out non-conformant implants to ensure patient safety and regulatory compliance.

Due to its accuracy, inherent design features and built-in functionalities, the XCEL DC100 is straightforward and efficient to operate and maintain. Setting up, dismantling and cleaning have also been engineered to be quick and easy, to reduce waste, human error and resource demand, improving productivity and reducing costs.

Learn more about the benefits of automated weight sorting in our latest blog >

Product Benefits

XCEL DC100 outperforms traditional checkweighers and laboratory balances for weight sorting subcutaneous implants.

Reduces human
interaction

Designed to run in
aseptic conditions

Accurate and consistent
batch-to-batch API dosage
at all throughputs

Lower QA/QC
testing times

Wash in place

Wash in place.
High IP rating

Easy to access and error-free data
in FDA-compliant templates

Maximise Productivity with High- Precision Implant Weight Sorting

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 24/7 unattended in aseptic environments and without any need for change parts, the XCEL DC100 minimises 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.

DC100 Benefit

Product Specification

Fast, high-precision weighing and sorting

Repeatability ±0.5mg to 3SD
High-performance option ±0.2mg to 3SD
Operating rate up to 1500 units per hour
Handles product between 1 and 3mm in diameter and 8 to 20mm in length
Built-in static elimination to prevent static-induced weighing variability

Optimised for aseptic manufacture

Designed to operate under laminar flow or full containment conditions
All contact parts, primary and secondary, are manufactured in 316L or PEEK
All other exposed materials are FDA compliant
316L and PEEK surface finishes are 0.5RA as standard (optionally 0.2RA)
Full material traceability
Primary contact parts can be readily removed for cleaning
All other surfaces (secondary contacts) are designed for clean-in-place
High IP rating
Primary contact parts are suitable for regular autoclave cycling

Detailed, compliant record-keeping

Full 21 CFR Part 11 and Annex 11 compliance
Complete audit trail and error logs
Role-based access rights
Security linked to site domain authentication
Server-based Data Manager (SQL database)
Full validation pack available to assist with compliance requirements

DC100

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:

Maximise productivity with limited resources

Maintain data integrity

Reduce manual tasks and human error

Avoid cross contamination and maintain quality irrespective of environmental factors

The XCEL DC100 solution

Automated, 100% weight sorting enables lab staff to focus on higher-value tasks

Pre-prepared, 21 CFR Part 11 compliant report templates allow for quick, easy and secure record-keeping

Automated and accurate readings are taken continuously

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:

Keep time to market as short as possible

Comply with multiple and varied regulatory frameworks

Control trial budgets

Maintain absolute consistency of API quantity to guarantee trial validity

Ensure uninterrupted supply of product to trial patients

The XCEL DC100 solution:

Total confidence in trial product quality due to 100% weight checking

100% weight inspection enables a coordinated quality and process control programme for verified trial compliance and data reliability

Data is collected at a fraction of the cost of manual weighing and recording

Quick, high accuracy, weight sorting based on expected API content safeguards trial investment

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:

Meet quotas, schedules and margins

Comply with regulatory requirements and maintain certification

Optimise processes and achieve consistent performance

Manage product handling for environmental factors

Deploy available workforce resources for maximum productivity and efficiency

Collect and analyse large amounts of data

The XCEL DC100 solution:

Benefit from outstanding accuracy and reliability matched with high flexibility

100% check weighing shows commitment to GMP

Minimised downtime - no costly change parts required

Designed for use in extreme environments and for products that require extra special handling

Maximise performance with tighter production tolerances, lower waste, higher yields and unattended running 24/7

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:

Reduce admin and maximise the value provided to customers

Reduce cycle times for issue resolution and frequency of deviations

Avoid bottlenecks in testing

Optimise operations to meet regulatory requirements

The XCEL DC100 solution:

Easier record keeping with automated data collection and 21 CFR Part 11 compliant templates

Fast sorting of weight defective products

Greater confidence to release 100% weight-checked production batches

Easy access to statistical and QC data for process optimisations

CI Precision — Your Trusted Technology Partner

When it comes to selecting an equipment vendor, choosing one that provides the right technology is just the start. To get the most out of your equipment in the long term, selecting the right partner will ensure your equipment is always performing at its best and delivering the payback you need on your investment.

Here at CI Precision, we are specialists in precision weighing and have over 50 years’ experience supplying weight sorters to leaders in industry. Our product development strategy is driven by our focus on enabling quality, performance and flexibility for our clients as well as our commitment to innovation and desire to deliver against industry gaps and needs. We are always looking for ways to simplify processes to help our customers achieve more with less.

The long-term partnerships we develop are a testament to our will and desire to work with our client partners to ensure our products and services are always delivering to their objectives. We work closely with clients to offer tailored solutions that fit best with their needs, and we are always more than happy to share our industry expertise to ensure project success.

Find out more about CI Precision

Delivering Exceptional Installation, Support and Maintenance Services

To help you get the best performance out of your weight sorter, day in and day out, we offer comprehensive project support as well as weight sorter installation, maintenance, repair and technical support services throughout the life of our equipment.

Some examples of what we offer as part of our extensive services:

Pre-sale visit to review installation requirements to ensure optimal performance
Assess alternative configurations where possible to suit specific containment requirements
Offer validation service options including OQ/PQ support
Provide support contracts to meet specific operational requirements