API and pharmaceutical CGMP manufacturing plant.

The Peboc-Eastman site was built to produce Vitamin D3 using proprietary technology and then significant investments were made to modernise the site and to provide capabilities for a broad range of CGMP processes using complex, multi stage organic synthesis. Peboc is currently an FDA-inspected CGMP manufacturing facility.

The buyer will find an up to date flexible and stand alone facility able to adapt production volume to several other chemical outputs.

Site Highlights

CGMP Inspected Site
‐ An FDA and MHRA inspected CGMP manufacturing facility, offering a range of capabilities for the production or organic intermediates and pharmaceutical excipients.
‐ Full range of scale from kilograms to hundreds of tons.
‐ Audited by more than 24 different multinational pharmaceutical customers.

Chemical and Analytical Development, including:
‐ A pilot plant.
‐ A CGMP small-scale manufacturing facility.

Manufacturing
‐ Well maintained, comprehensive mix of multipurpose equipment designed for a wide range of CGMP and other fine chemical applications .
‐ Synthesis is carried out in multipurpose batch reactors in glass and stainless steel ranging from 100 L to 4500 L (0.1 M3– 4.5 M3).
‐ Total plant capacity is approximately 75000 L.
‐ Facilities include a broad range of equipment for the handling of both liquids and solids.

Production
‐ Recent production includes 5 products totalling 9 chemical steps. 

Excellent Safety Record
‐ Safety performance is very good
‐ All manufacturing areas are flameproof
‐ Site designed to handle volatile and highly flammable materials.

General Site Presentation

Manufacturing is based in two production buildings divided into both General-Purpose and CGMP batch plants, a CGMP hydrogenator, a small-scale CGMP manufacturing unit and a CGMP kilo laboratory.

Ancillary Facilities Include:
‐ A 500 sqm quality control laboratory with segregated wet and dry technique areas with full instrumentation to support CGMP.
‐ A weighing area,
‐ Stability testing area,
‐ Offices and conference room;
‐ CGMP finishing rooms,
‐ Support services, for example, purified water and a flameless thermal oxidiser for VOC Control.
‐ Lease of a 1600 sqm technology centre housing development laboratories & development analytical laboratory; high pressure laboratory & special gases laboratory;


Products Previously Produced at the Site
‐ Pharmaceutical API’s & intermediates
‐ Custom synthesis of high value fine chemicals

Capabilities
‐ LAB > KILO LAB > PILOT PLANT > FULL SCALE CGMP PRODUCTION
‐ Flexibility to adapt to alternative production


A Stand alone API and Pharmaceutical Unit
‐ Flexible production Unit
‐ Manufacturing expenses and related production materials of around 10 M€ in 2006

Land and Building Area
‐ Total: A site of approximately 55 acres*
‐ Developed: Approximately 12 acres – available building land: 150 845 SQM
‐ Warehouse 2 X 580 SQM & 1 x 380 SQM
‐ Production 1025M2 building area
‐ Administration 2400 SQM & social 950 SQM total floor area
‐ Subject to obtaining satisfactory consent to assign a technology centre of 1060 SQM.
‐ Quality control 500 SQM

Physical Technologies
‐ Stirred batch reactions
‐ Clarifications to remove insolubles or to decolourise
‐ Crystallisation
‐ Filtration (product isolation) including centrifugation
‐ Vacuum or atmospheric distillation
‐ Extraction
‐ Separation via decant or filter leg
‐ Solids drying and CGMP pack-out
‐ In- process solvent recovery.

Regulatory Assurance
Peboc has an excellent regulatory record. Safety performance is excellent; under Eastman management ther have been no OSHA days away from work for over ten years and only one OSHA recordable incident for over three years.

Environmenetal performance is good and there are good professional relationships with Health, Safety and Environmental regulators.

The Environment Agency audited the site in December 2006,


MANUFACTURING CAPABILITIES

Chemistry
Hydrogenation, Condensation, Esterification, Etherification, Chlorination (HCl, Cl2, SOCl2, POCl3), Bromination, Grignard, Amination, Oximation, Alkylation, Nitration, Asymmetric Synthesis, Optical Resolution, Enzyme CatalysisList of Main equipment

Kilo Lab
1 107 litre Buchi Glasuster glass lined reactor with glass top, glass flasks, condensers and pipe-work


Glass lined reactors

2 340 litre Pfaudler
1 450 litre Pfaudler
1 680 litre Pfaudler
5 1365 litre Pfaudler
1 2180 litre Pfaudler
1 2250 litre Pfaudler
1 2500 litre Pfaudler BE with cryo-lock agitator
2 2500 litre DeDietrich BE with glaslock agitator
6 4000 litre DeDietrich BE with glaslock



Glass lined tanks and receivers
1 18185 litre Vertical
1 29400 horizontal
5 2500 litre DeDietrich vertical jacketed receiver
1 1420 litre DeDietrich vertical jacketed receiver
1 850 litre DeDietrich vertical jacketed receiver
3 650 litre DeDietrich vertical jacketed receiver



Stainless Steel Reactors

5 1365 litre
10 2250 litre
1 2700 litre

Hydrogenator
1 1280 litre 65barg Hastalloy reactor with feed and filtration equipment

Centrifuges
1 36" dia halar lined basket
1 48" x 16" stainless steel bottom discharge
1 48" x 24" stainless steel bottom discharge
1 48" x 24" Hastalloy bottom discharge

Filters and Dryers
1 3580 litre Draiswerke Type HT 3000 titanium lined turbulent vacuum paddle dryer
1 2000 litre Comber PH2000 Pharmadry Hastalloy C22 polished vacuum paddle dryer
1 1 sq.m Guedu 316L agitated Nutsche filter/dryer with side discharge
1 750 litre Mitchell 316 SS 4 trolley tray dryer
1 4 sq.m Wm Boulton 316 stainless steel vacuum shelf dryer

Ancilliary Equipment
Star low temperature Refrigeration systems
Laminar flow booths and cabinets with HEPA filtration
Le Carbone Graphite block condensors
Barriquand Hastalloy plate heat exchangers
Edwards Type DP250 & DP160 high vacuum systems
SIHI liquid ring vacuum pumps
Bagging/drumming systems
Pumps
Cartridge filters
Cochrane steam boilers
HPC Pulseair screw compressors
CompAir Broomwade Cyclon 6000N screw Compressors
500kVA diesel standby generator
Air Handling systems
Scrubbing systems
Drum Heaters
QVF glassware
Glatt GS180 316 stainless steel cone mill
Tank Farm
Tanker loading/unloading systems