OSHA Inspection: LEDERLE LABS

Issued

May 5, 1999

Abate by

Jun 9, 1999

Penalty

Initial $2,125 · Current $1,325 Reduced

General-duty citation text

Section 5(a)(1) of the Occupational Safety and Health Act of 1970:  The
employer did not
furnish employment and a place of employment which were free from
recognized hazards that
were causing or likely to cause death or serious physical harm to
employees in that employees
were exposed to the hazard of fire and/or explosion due to deflagration of
a combustible dust
atmosphere:
On or about December 7, 1998
Location: 100 Complex - Littleford Charging Room - 5th flr.
Littleford Blender - 4th flr.
a) Employees required to charge the Littleford blender with BASF
Crospovidone CAS # 9003-
39-8 during batch making operations and blending operations of Centrum
vitamin mixtures, were
exposed to a fire/explosion hazard as a charge in the packaging material
of the crospovidone,
consisting of a plastic coated aluminized liner, introduced an
electrostatic
ignition source.
Written plant change procedures do not address the safety and health
implications of any changes
as per NFPA 654-1997 edition - section 2-8.1(b), rather only deal with
quality control
specifications for the various production components and the final product.
Among other methods one feasible and acceptable abatement method to
correct the hazard
observed in instance "a" is to: modify the current plant change procedure
to address the "safety
and health" implications of any proposed changes.
b) Employees required to charge the Littleford Blender with BASF
Crospovidone - CAS #9003-
39-8 during batch making and blending operations of Centrum vitamin
mixtures were exposed
to a fire/explosion hazard as the installed dust control and collection
system(s) were not
adequately inspected, tested and maintained.  An employee GMP hair net was
found in the
corrugated ventilated duct to the charging hood which compromised the
function and
performance and thereby reduced continuous suction in accordance with NFPA
- 654 - 1997,
Section 4-1.1, and in accordance with NFPA 654 Section 8-1.1. NFPA 654.
c) Employees required to charge the Littleford Blender with BASF
Crospovidone - CAS #9003-
39-8 during batch making and blending operations of Centrum vitamin
mixtures were exposed
to a fire/explosion hazard as the installed dust control and collection
system(s) were not
adequately inspected, tested and maintained.  The suction for the Blender
was effectively blocked
and minimized as approximately six (6) to (8) inches of dust product on
top of a paper covered
metal grate was allowed to accumulate inside of the Coleman Filter and
interfered with the
function and performance of the dust collector and did not allow the
conveyance of dust in
accordance with NFPA - 654 - 1997, Section 4-1.1, and in accordance with
NFPA 654 Section
8-1.1. NFPA 654.
Among other methods one feasible and acceptable abatement method to
correct the hazard
described in instance b and c is the development and implementation of the
following:
1.) Install visible/audible alarms to monitor ventilation pressures
(magnehelics or other similar
ventilation airflow meters) to ensure that a continuous suction to the
dust control and collection
system components is maintained.
2.) Ensure that the dust control and collection systems are inspected and
maintained as was
originally designed to minimize the potential for any hazardous
atmospheres.
d) Employees required to charge the Littleford Blender with BASF
Crospovidone - CAS # 9003-
39-8 during batch operations and blending of a Centrum vitamin mixture
were exposed to a
fire/explosion hazard as all the components of this process system were
not electrically
conductive. Drums of Crospovidone (packaged in plastic coated aluminized
liners) were not
individually electrically connected (grounded and/or bonded) to the Ajax
Shaker Dump Hood
/ Littleford Blender process equipment when dumped into and shaken out
over the charging
station, and thereby introduced a source of ignition (i.e. static
electricity spark discharge)
capable of igniting the explosive air/dust atmosphere as per NFPA 654 -
1997 edition - Sections
5-3 and/or 5-5.2, respectively.
e) Employees required to charge the Littleford Blender with BASF
Crospovidone CAS # 9003-
39-8, were exposed to a fire/explosion hazard as all the process
components of this process
system were not conductive, including but not limited to, charging station
work platform, Russel
Sieve, Ajax Shaker, non-conductive flexible ventilation and transfer hose,
and the butterfly
valve. Each of the above components were isolated and not electrically
interconnected (grounded
and/or bonded) to this process equipment as per NFPA 654 -1997 edition -
Section 5-3.
Among other methods one feasible and acceptable abatement method to
correct the hazard
described in instance d and e is the development and implementation of the
following:
1.) All system components shall be conductive. Provide bonding and
grounding of all system
components with a resistance of less than 1.0 x 10 sixth power ohms to
ground shall be
provided. (Reference NFPA 654-1997 Section 5-3.1.)
2.) Raw materials shall only be packaged in appropriate containers and in
an appropriate manner
so as not to introduce an potential sources of ignition.
3.) Provide employees with conductive shoes.
f) Employees required to charge the Littleford Blender with BASF
Crospovidone - CAS #9003-
39-8 during batch making and blending operations of Centrum vitamin
mixtures were exposed
to a fire/explosion hazard as explosion protection system required by NFPA
654 Section 3-6
were not inspected, tested and maintained in accordance with NFPA 654
Section 8-1.1.
Approximately six (6) to (8) inches of dust product on top of a paper
covered metal grate
accumulated inside of the Coleman Filter and interfered with the function
and performance of
the explosion protection system as this material and the grate effectively
blocked the explosion
discharge venting hole, and in that the installed and modified pressure
relief rupture disk (26"x
49" FIKE CVSF) was not designed, maintained and tested in accordance with
NFPA 654 - 1997,
Section 8-1.1, to perform as per the specifications of the original
design.Among other methods one feasible and acceptable abatement method to
correct the hazard is the
development and implementation of the following:
1.  Provide an inspection, testing, and maintenance program that ensures
that the explosion
protection systems and related process controls and equipment perform as
designed and that a
change in process equipment does not increase the hazard.
NOTE: In addition to abatement certification, the employer is required to
submit abatement
documentation for this item in accordance with 29 CFR 1903.19.

Issued

May 5, 1999

Abate by

May 17, 1999

Penalty

Initial $2,125 · Current $1,000 Reduced

Issued

May 5, 1999

Abate by

Jun 9, 1999