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Frequently Asked Questions

Facility Questions:

What Certifications, Claims and Registrations does LaunchWorks ML have?

Our facility has been ISO 13485:2003 certified 3 times since 2011 and during our most recent inspection we received no major findings.  In 2017 we also now claim cGMP compliance along with being registered with the FDA, Registration number 10055461

How large is LaunchWorks Manufacturing Lab?

We operate a 30,000 sq. ft. facility which includes our open floor plan Class 10,000 lab space, assembly floor, cold storage and warehousing space.  Also included are our two truck level loading docks, where incoming products are received and inspected into our climate controlled warehouse. (See: How are incoming materials handled and confirmed to enter production?

How clean is the LaunchWorks Manufacturing Lab?

We operate a Class 10,000 certified cleanroom lab with Class 100 work environments.  We also do not work with live biologic samples or API’s and live materials do not enter our facility.  This provides an additional level of assurance that our customer’s products will not come into contact with biologics

What are your standard storage environment temperatures’?

LaunchWorks stores materials in all phases of production as specified by the manufacturer or customer.  We store products at ambient, +4C, -20C, or -80C.

Do you have environmental monitoring systems?

Yes, all our manufacturing environments and cooling units are monitored, temperatures logged and room humidity tracked within our ISO 13485 compliant QA system. All chambers are monitored by validated temperature loggers with real time reporting and an active responder 24/7.  There is a natural gas powered backup generator for all chambers.

Do you have back up power systems for your cooling units in case of an outage?

Yes, LaunchWorks has all cooling units on a backup power system.  The heart of the system is a natural gas fired generator.  Additionally, this system is backed up by a local cold chain trucking company that can supply monitored cold storage at our docks on short notice. This triple redundancy ensures complete protections of all customer raw materials, WIP (work in progress) and finished goods.

Can you perform warehousing and distribution services?

Yes, we provide warehousing, cold storage, and worldwide cold chain distribution service options for our customers.  We use premiere services and practices in collaboration with our vendor to assure that our customers products arrive on-time and in condition.

Do you offer in-shipment logging?

Yes, we support the use of loggers and indicators manufactured by Cryopak for monitoring our customers’ product depending on the specific needs of the shipment.  Ask us about meeting your specific cold chain monitoring requirements!

 

Manufacturing Questions:

What type of products do you manufacture?

We manufacture a wide range of custom formulated reagents, buffers and solutions for use in products in genomics, NGS, proteomics, immunoassays, DNA & RNA prep kits, collection kits and more.  Additionally, we offer a number of supporting services including: graphic & packaging design, kit box printing, kit assembly, supply chain management, warehousing and cold chain shipping.

Will you assemble medical devices?

We do assemble components and finish medical devices.  While we handle electronic components we do not assemble them. Components we have assembled are in the IVD, Buffers, Sample preparation, Companion Diagnostics areas of concentration. Please talk to us about getting clarity on this topic as each clients’ needs are different and our goal is to make it as cost effective as possible for you to do business with us.

How are incoming materials handled and confirmed to enter production?

We follow our QMS that has been TUV certified to ISO 13485 and conforms to cGMP guidance.  Our best practices allow us to manufacture at very high yields with zero returns.

What is your lot tracking process and how does the customer get assurance of its integrity?

Launchworks has various SOP and Work Instructions in place to ensure that all raw materials, work In-progress, customer provided material, and components and finished goods are reconciled at all times.  We have full transparency around our processes, this information is available for customer review upon request.

How do you manage finished goods?

We handle all product, raw materials, work in progress & finished goods with extreme care.  Our customers finished goods are safeguarded under the LaunchWorks Manufacturing Lab QMS (Quality Management System) and inventory control system.

Do you have methods for improving your manufacturing and reducing costs over time?

LaunchWorks Mfg. Lab uses specially adapted LEAN manufacturing methodologies.  Our culture of continuous improvement empowers all our employees to get clarity and suggest changes that eliminate any of the 8 Traditional Wastes of Biotech Manufacturing and ultimately drive value to our customer.  We maintain a culture of operational excellence that all employees contribute to!

 

QA and QC Questions

Have you ever had to recall products or lots?

Since our first commercial shipment in 2010 we have never had to recall a product and never received a return of a shipment due to a defect in the product.

How many QC stations/steps do you typically have?

Every step of the process has QC steps involved.  We use a redundant ISO 13485 compliant system that is specifically designed to verify that what is made is exactly as the customer has specified. Our team takes ownership of the customers products as their own.

Can I hold a meeting with your QA staff?

Our management style is to be fully transparent and we openly invite our customers to directly speak to any level of our staff.  We maintain an open door policy so customers may stop into our facility as they feel necessary.

What are your standard storage environment temperatures’?

LaunchWorks stores materials in all phases of production as specified by the manufacturer or customer.  We store products at ambient, +4C, -20C, or -80C.

 

Don’t See your question?

Please use the form below to ask your question,  and the proper person will get back to you by the end of the next business day.  If that is not fast enough, call and ask for Jason or Tom.

Connect with us today to learn more about how LaunchWorks can partner with you to improve the speed and efficiency of your manufacturing processes.

 

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Contact Us
LaunchWorks Manufacturing Lab
123 Brimbal Ave.
Beverly, MA 01915
Phone: 978-338-3045
info@launchworksml.com