For many years I was responsible for ALL DISCHARGE STATIONS AS WELL AS FOR
EVERY THING ELSE IN PKG & MFG from technical point of view (what does not
limit my contributions in all other aspects/areas of the business).
We had many Discharge Stations.
All of them were negatively affected by pending construction, absence of
spare parts, limited /with out experience Personnel, production of NEW
This time I want to focus your attention on Discharge Stations addressed in
attached e-mail to Manager and opinionated by one of new MFG Supervisors
(shortly after / promptly left the Company), especially from New Products
New products were very, very potent, under formulated with no proper in
selection or quality ingredients, of wrong moisture , of wrong
lubrication/viscosity, of problematic crystal structure / specific weight
as well as due to many more problems / factors etc.
All of this while added up to compromised equipment, contributed to problems
with gravitational discharge of those products from Gallay Bins installed on
upper Floor and down trough docking chute and down the PVC lay flat in to
the hoppers and in to feed frames and further in to the tooling in process
All those problems forced Company to have an Operator standing over each
open/ unsealed Bin containing restricted active (in clearance of 2 fit in
between ceiling with long S.S. rod inserted in to the Bin and working
/pushing the product down the butter fly valve out of the bin in to the
Often/usually the BIN had to be raised up off the station and docking chute
disengaged in order to get the product moving.
Often/usually the Operator was getting very tired and high on the product
rupturing the PVC sleeve in the process of pushing the product.
Often/usually disengaged chute dropped out of control or the PVC sleeve GOT
pinched on the hopper prompting massive and uncontrolled products discharge
Often/ usually product got packed up /compressed inside of the Bin or inside
of feed frames and had to be manually removed during process by Operators
with out any protection.
ALL OF THESE AND MANY MORE OBSTACLES CONTRIBUTED TO CONSTANT UNCONTROLLED /
MASSIVE PRODUCT DISCHARGES ON THE PERSONNEL, EQUIPMENT, FLOORS CAUSING DAILY
MULTI PRODUCT CONTAMINATION/ CROSS CONTAMINATION AND ADVERSE SIDE EFFECTS ON
While on daily bases we did process very many products parallel on all
peaces of equipment , very many of them had to be simply scooped by hand all
shift long, causing direct exposures to all personnel (very adverse side
effects) and gross contamination .
Most of the "bad" products Company processed on the night shifts, often
bringing products from other Facilities and removing / shipping them
promptly out in the morning.
Operators/Personnel did not have protective glasses, gloves , uniforms and
any thing else.
No GMP, no SOP, no SAFETY:
.FALSIFICATION OF CALIBRATION AND PRODUCTION DOCUMENTATION.
.CROSS CONTAMINATION OF THE PRODUCTS ( use of dedicated equipment and direct
product contact parts ) FOR MULTI PRODUCT PRODUCTION.
.TEMPERING WITH NEW PRODUCTS, MANUAL PRODUCTION OF SAMPLES FOR FDA
.ALTERING PROCESSES (manual runs of the equipment or subassemblies, recipes
are not executed by PLC and installed /down loaded programs/software) BUT BY
.EQUIPMENT OPERATED BY CONTRACT OPERATORS WITH OUT EXPERIENCE AND WITH OUT
ANY SUPERVISION (CROSS CONTAMINATING PRODUCTS AND THEMSELVES), with out in
process quality control.
.DUE TO CONSTRUCTION / STRICT CONFIDENTIALITY ALL SAFETY DATA SHITS WERE
REMOVED FROM ALL LOCATIONS.
.WORK ORDERS NOT POSTED ON THE DOORS OR NEXT TO OF PRODUCTION ROOMS.
.OPERATORS AND MOST MECHANICS ARE KEPT IN THE DARK IN REGARD TO THE NATURE
OF THE PRODUCT THEY PROCESS.
.DUE TO FACT , THAT PEOPLE/EMPLOYEES DID NOT WANT TO WORK WITH NEW
/DANGEROUS PRODUCTS AND MANY OF THEM LEFT, DUE TO ABSENCE OF PERMITS , LEGAL
ISSUES etc. ,COMPANY STARTED TO WITHHOLD INFO ABOUT PROCESSED PRODUCTS.
.IMPORTED AND DOMESTIC ACTIVE INGREDIENTS NOT INSPECTED/TESTED PRIOR TO
.IMPORTED FROM ASIA PRODUCTS ARE REWORKED AND REPROCESSED TO DIFFERENT
.CONTAMINATED PRODUCTS ARE COATED IN ORDER TO CONCEAL CONTAMINATION.
.DEDICATED PROCESS EQUIPMENT NOT SANITIZED AND USED FOR MULTI PRODUCTS.
On one circumstance on night shift I was called to attend emergency
situation in one of the process Rooms.
As soon I arrived I noticed an Operator unconscious on the floor.
When I pulled him out of the Process Room (the rooms looked as Nazi gas
chambers) by the legs he was disposed off by his follow Taliban Operators.
Apotex selected to employ Taliban/ Alquida, facilitated and nurtured their
culture in the facility (organized pray rooms etc.).
Apotex did allow Taliban / Alquida to organize and work with out any
restrictions / supervision with highly potent controlled substances /
narcotics (no production supervision of any kind, no in process quality
control of any kind, no quality control of incoming materials of any kind,
no adequate sanitation of equipment/product holding bins etc.) Dedicated
equipment used for multi products. Apotex was exterminating employees of
Taliban / Alquida orientation by not providing them with any product info
and personal protection. That promoted products induced violence at work /
antidepressant nightmares. I was physically and verbally attacked many times
at work / in Facility) by Operators high on actives. Taliban did cause my
right hand severe injury and time off work in 2001. As always Company did
not report it to WSiB.
I believe that drugs produced during some periods of my employment killed
more people world wide then military operations in Iraq, Afghanistan