BOSTON, MA
A Letter from Leadership
On behalf of our 100+ associates here, welcome to Catalent Boston! We are pleased to offer you a tour of our state-of-the-art facility and introduce you to our unmatched expertise in the development, optimization, and commercialization of inhalable dry powders. The key to our success is in our process expertise and the relationship with our customers. Our objective is to create a partnership for us to meet your needs and provide solutions for your challenges. The Boston team prides itself on providing exceptional service and products of exceptional quality that bring better treatments to market. This is driven by Catalent’s Patient First culture, one that puts patients at the center of our work to ensure the safety, reliable supply, and optimal performance of our products. We look forward to partnering with you to reliably supply your next inhaled molecule from development all the way through commercial launch.
Gordon Ashton
Site General Manager
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Visitor Health Statement
Novel Coronavirus (COVID-19)
Catalent is committed to the health and safety of its employees, visitors, and the customers and patients we serve. In light of the Coronavirus outbreak, we have put in place restrictions on access to our sites.
By entering this facility, I affirm that I have not experienced any of the following symptoms within 72 hours of visiting the site:
- Fever or chills
- Congestion or runny nose
- Cough
- Nausea or vomiting
- Shortness of breath or difficulty breathing
- Diarrhea
- Fatigue
- Headaches
- Muscle or body aches
- New loss of taste or smell
- Sore throat
Catalent takes the health and safety of its employees seriously. As such, if you should exhibit the symptoms of, or test positive for, COVID-19 over the next two days, we request that you contact your Catalent host, so that Catalent can take all possible measures to prevent the spread of the virus.
Site visitor guidelines are dependent on local regulations as well as local pandemic status and are subject to change. Your site host will advise on any changes outside of this document prior to visit.
Key Boston Site Information
The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro PSD1, PSD4 and PSD7, the latter being the largest CGMP unit of its kind for DPI in North America. With clinical- to commercial-scale spray drying and manufacturing, paired with inhalation development expertise out of our Boston, MA site, the Catalent network can help bring your inhaled molecule from any point in development through product launch and beyond.
Manufacturing work is supported by an on-site, 7,850 sqft QC lab and a 15,200 sqft warehouse with advanced sample and inventory management systems. Production suites are ISO 8 with dedicated air handling and top-tier Harro Hofliger and Pharmaworks encapsulation and blister packaging lines. The on-site operations team is well-versed in spray dry technology and commercial DPI capsule manufacture, with a credible track record of FDA and EMA compliance.
The 96,000 ft. 2 facility is conveniently located only 10 minutes (3.1 mi) from the Boston Logan International Airport (BOS).
SECURITY
- Please park in visitor-designated parking areas.
- Please observe speed limits and stop signs while driving on the premises and yield to pedestrians.
- All vehicles and articles are subject to inspection.
- Visitors are issued and must wear a name tag or contractor badge at all times while on site. All visitors are required to check out at the Kiosk before leaving the site.
- Visitors should be accompanied by an employee at all times within the facility.
- Taking photographs or videos is not allowed on site.
- Weapons, including privately owned firearms, are strictly prohibited on plant property.
- All persons visiting the site must be pre-registered by the host or register at the front desk or security desk by providing a formal government issued ID.
SAFETY & EMERGENCY
- You will be provided with personal protective gowning requirements relevant to the areas visited during your stay. Jewelry will need to be removed prior to entering GMP Production areas.
- Accident or Injury – If you have an accident or feel ill, inform your host who will arrange for first aid.
- In the event of a fire emergency, a long continuous alarm will sound. Your Catalent host or a member of the fire marshal team will escort you to the nearest exit door.
GOOD MANUFACTURING PRACTICES (GMP)
- The Pharmaceutical facility adheres to regulatory requirements under Federal Law for Good Manufacturing Process (GMP).
- For safety, footwear should be closed toe, no sling-back (for ladies), and a low heel.
SIGNS & WARNINGS
- Please be aware of displayed warning/personal protection signs and adhere to instruction issued by Catalent staff.
- Follow all posted signage relating to COVID-19, i.e. wearing masks, social-distancing, handwashing, etc.
- Do not enter restricted areas or touch any product, materials, machinery controls or equipment, unless authorized to do so by a Catalent employee.
IT
- Catalent offers wireless internet access for our guest. Your host will pre-register you and make arrangements for internet access during your visit.
- Catalent provides guest printing services. For assistance, please contact your host.