APPLICATION
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CONCEPTS ASSOC. INC.
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August 9, 1995
Planning & Zoning Dept.
City of Boynton Beach
100 E. Boynton Beach Blvd.
Boynton Beach, FL., 33425
Re: Request for use approval in Quantum Corporate Park
To Whom It May Concern:
The Boynton Beach Planning & Zoning Dept. have requested the following
information and statement per our request to use our anticipated
manufacturing plant in the Quantum Corporate Park per the City of
Boynton Beach Performance Standards & Ordinances.
To respond to Section N "Performance Standards" of the City of Boynton
Beach, Municipal Code, one must know the scope of Packaging Concepts
Assoc. Inc. (PCA) anticipated activities which can be broken down as
shown below. In brief, PCA is engaged in the R & D of non-aerosol
spray dispensing systems; in the manufacture of its new patented MPAK
plastic spray dispenser and in the manufacture of OTC (over the counter)
drug and other chemical specialty liquid products.
Plastic Injection Molding:
We currently have tooling for the 0.5, 1.0 and 2.0 FL.OZ. MPAK plastic
spray dispenser unit with a 4.0 FL.OZ. size in progress. The MPAK unit
is unique in being a small, compact non-aerosol spray dispenser with
a locking feature. The unit also is fully assembled ready for product
filling without the need for concerns to purchase all the components
needed for a comparable package. To produce the MPAK dispenser, we
plan to install plastic injection molding machines. The number of
machines required is not known at this time, but we anticipate a start-
up of atleast one machine per MPAK size.
Printing:
Each MPAK plastic dispenser will be offset decorated for its required
labeling and product identification. We use a special offset blanket
type printer that uses non-toxic UV inks especially made for plastic.
The UV inks are instantaneously cured and L~~e permanent when auto-
matically exposed to an UV light source concealed within the printing
machine.
Continued:
From Initial Concept To Finished Product
5700 Lake Worth Rd. Suite 20"B . Lake \'>;'orth. FL ~3463 . Tel (40"') 96"-1130 . Fax. (407) 965-4714
POBox 33"4 . Bridgeport CT 06605 . Tel (203) ~84-8913 . Fax. (203) 334-0405
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CONCEPTS ASSOC. INC.
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Assembly:
In order to make a working MPAK spray dispenser necessary components
must be attatched to the basic plastic tube. We plan to automatically
insert a mechanical non-aerosol pump module and then affix an actuator
in the locked position to the printed tube. The tube bottom is left
open for product filling to which a bottom piston seal is affixed to
make a secure package.
Compounding:
The Compounding Dept. is a very important part of the PCA facility.
It is here that the various liquid products are compounded (ingred-
ients added & mixed) per approved customer or PCA formulations. The
area and equipment must be kept clean at all times to insure against
contamination. This area is supervised by a graduate chemist and
other personnel to maintain the high standards of quality products.
These personnel are guided by PCAls Standard Operating Procedures
(SOP) and also Good Manufacturing Practice (GMP) rules per FDA
guidelines.
Liquid Packaging:
PCA plans to liquid fill & package the MPAK dispenser per the require-
ments of its customers. The liquid filling machines are standard in
the trade that automatically fills the MPAK unit to the exact label
contents or weight statement. The products involved will over-the-
counter (OTC) drugs, i.e., Hydrocortisone Spray, Topical Anesthetic
Spray, etc. Also, chemical specialty products, i.e., Eyeglass Cleaner,
Breath Freshener, Deodorants, etc. All the products produced will be
non-toxic to both human and animals. In order to produce OTC drug
products, the PCA plant will be registered with the U.S. Dept of
Food & Drug Administration as a "drug establishment".
Dry Packaging:
Dry packaging is the final MPAK phase. At this time, we have three
different packaging options for our packaged product going out in
commerce:
1- Bulk pack into a large master shipper.
2- Units packaged in decorated counter displays and then
packed into a master shipper
3- Blister card packing
We will probably use all three options per our customers requirements.
Continued:
From Initial Concept To Finished Product
'5700 Lake Worth Rd. Suite 205B . Lake Worth. fL ~346~ . Tel. (40~) 965-1130 . Fax. (407) 96'5-4714
POBox 3354 . Bridgeport CT 0660'5 . Tel. (203) 384-8913 . Fax. (203) 334-0405
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CONCEPTS ASSOC. INC.
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Quality Assurance Dept.:
To assure the quality of its production, the PCA facility will have
a Quality Assurance Dept. to conform to FDA & EPA's requirement of
Good Manufacturing Practices (GMP). This department and its personnel
is charged with the responsibility to maintain strict quality control
of every manufacturing operation from the molding of the virgin MPAK
tube until the final dry packaging operation. It will also have state
of the art electronic analytical equipment to insure that the products
produced are in complete specification to prescribed approved standards.
City of Boynton Beach Municipal Code
N. Performance Standards:
#l-Noise: Sec. 15-8 Noise Control-
PCA's manufacturing functions will only produce low level noise inside
the building and absolutely no noise outside the building. PCA shall
not be in violation of any provision contained within Sec. 15-8 thru
Sec. 15-8.8 of the City of Boynton Beach Municipal Code or applicable
ordinances.
#2-Vibrations:
The PCA production equipment such as the injection molding machines
or liquid filling equipment are not capable of producing any percep-
tible vibration inside or outside of the building.
#3-Smoke,Dust, Dirt or other particulate matter:
Since the PCA facity must conform to FDA's GMP regulations, we cannot
have or tolerate any smoke, dust, dirt or other particulate matter
within the plant environment. In fact, some areas such as the OTC
drug liquid fill area will have special overhead filtration system
to maintain the clean integrity of the area.
#4-0dors & Fumes:
While fragrant liquid products will be produced in this facility,
we do not anticipate odors or fumes to be perceptible outside of
the building. We do not anticipate making products that will generate
fumes.
#5-Toxic or noxious matter:
Since all PCA products are either taken orally or used topically on
the skin of humans, we cannot have toxic or noxious materials in the
plant or be used in its products.
#6-Fire and explosive hazards:
The MPAK spray dispenser is a non-aerosol mechanical type pump that
does not require any propellant for atomization. The liquid products
being produced by PCA may require either tax paid pure alcohol or
From Initial Concept To Finished Product
Continued:
')""00 Lake Worth Rd. Suite 20')B . Lake Worth. FL 3~463 . Tel (40"") 965-1130 . Fax. (407) 965-4714
POBox 33')4 . Bridgeport. CT 0660') . Tel (203) 384.8913 . Fax. (20~) ~34-040,)
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CONCEPTS ASSOC. INC.
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or specially denatured alcohol (SDA). While alcohol is flammable, PCA
will work closely with the Boynton Beach Fire Dept. to store and use
this commodity in conformance to Chapter 9 of the City of Boynton
Beach, Code of Ordinances. PCA must also work closely with the u.s.
Bureau of AT&F, who regulates the use, shipment and storage of alcohol
for non-beverage use.
#7-Heat, humidity or glare:
The PCA production equipment & machinery should not produce external
heat, humidity or glare. In fact, the entire plant will be air condi-
tioned with humidity controls since humidity can affect the quality
of the offset printing process and other packaging operations.
#8-Liquid Waste:
PCA does not anticipate having an excess of liquid waste. The only
real liquid waste anticipated is the clean-up wash water for the
cleanliness and sanitization of the compounding batch tanks and liquid
filling lines between product runs. In order to prevent any liquid
waste getting into the Boynton Beach city waste water collection system,
a special liquid waste collection arrangement will be used. This waste
will be pumped into a special large holding liquid waste tank to be
pumped out by a private, approved disposal company. PCA shall not be
in violation of any provision contained in Sec. 26-112 thru Sec. 26-
408 of the City of Boynton Beach Code of Ordinances.
#9-So1id Waste:
The solid waste generated by PCA will be corrugated and other paper
packaging waste together with misprinted, rejected printed plastic
tubes suitable for recycling. No PCA solid waste will be in violation
of Chapter 10 of the City of Boynton Beach Code of Ordinances.
#lO-Electromagnetic Interference:
PCA has no equipment to cause or create radiation or other electro-
magnetic interference in or outside the plant.
#ll-Hazardous materials & Waste:
As noted above, PCA will produce products for human consumption and
use as OTC drugs, possibly prescription drugs and other cosmetic and
specialty products. It is quite possible that PCA may dedicate a
portion of the plant which will be segregated to produce a pesticide
product, such as an Insect Repellent for topical human skin use. The
area would be isolated together with the packaging equipment and
wholly independent of the normal, human GTC productive area. If we
elected to produce this type product we would have to register with
EPA and be guided their regulations for pesticide products. As noted
above, any hazardous waste material would be disposed of using private
hazardous waste disposal companies.
Continued:
From Initial Concept To Finished Product
5700 Lake Worth Rd. Suite 205B . Lake W'orth. FL 33463 . Tel (40~) 965.1130 . Fax. (407) 965-4714
POBox ~3'i4 . Bridgeport CT 06605 . Tel. (20~) 38't.8913 . Fax. (203) ~34.0405
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CONCEPTS ASSOC. INC.
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Certification:
Packaging Concepts Assoc. Inc., hereby certifies to be in compliance
with each of the ten numbered portions of Paragraph N. on a continuing,
permanent basis. Also, to hold harmless and indemnify (in perpetuity)
the City of Boynton Beach from actions brought relating to activities
outlined in Paragraph N; including but not limited to Consultant and
Attorney fees; and provide irrevocable surety for each.
Note:
PCA will respond to Sec. 11-3, "Environmental Review Permits" of the
City of Boynton Beach, Code of Ordinances separately and prior to
the issuance of a building permit, as required by city codes
4f;esp tfully,
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Edwin I. stoltz,
Vice President &
Director
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cc: Mr. Philip Meshberg, President
Mr. Jeff Lis, Catalfumo Construction Co.
From Initial Concept To Finished Product
5700 Lake Worth Rd. Suite 205B . Lake \\'orth. FL 33463 . Tel (40~) 965-1130 . Fax. (407) 965-4714
POBox 3354 . Bridgeport. CT 06605 . Tel. (20~) 384-8913 . Fax. (203) 334-0405
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/ PACKAGING
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To:
Tim Page/catalfumo
Date:
6/5195
Fro~; Dr. F,d Stoltz
Pg.l/3
Subject: peA Operation
Copie:s To: phil Mesl1berg
Tim: Here is the w.cite-up that we would like you to revised, etc.
for the necclS5ary a:pprovals by the Boynton Beach agencies.
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Packaging concepts Assoc. Inc. (peA) proposed Manufacturing Act1vities,
to be done at: 4975 park Ridge Rd., Quantum Corporate Park, Boynton
~e~ch, FL., 33436.
!.!!.!Epduct1.on;
PCA'~ manufacturing activities can be divided into the following
several a.reas:
I-Injection Moldin\) of Plastic Tubes
2-Tl1bEl! Assembly
3-Liquid Packaq1ng
4-Quality Assurance
5-P~rsonnel
~ach of the general classifications shown above wtll be described below:
Injec~ion Mold~ng of plastic Tubes:
peA, a 1"'lorida corporation, was formed by Mr. Philip Meshberg to
d~siqn and manufacture new non-aerosol dispensing systems. peA works
Wlth their customer to develop from its concept and follow through
t.o the finished product the "package". Mr. Meshber9, who has been
1n the aerosol and non-aeroBol dispensing business for some 45 years
has developed a new patented plastic container that we call "MPAKJI.
This MPAK container will be the backbone of the peA operation in
Boynton Beach. As reference point of information, Meshberg is the
inventor o~ the first metered aerosol valve that is used by millions
01 peopie worrd-wl~e who suffer from asthma and other maladies.
The peA operation is totally dedicated to the 9on-aerosol dispensinq
method of spraying drug and other products using-the MPAK plastic
tube Without gett1ng too technical, peA's MPAK is a molded container
made of poiypropylene and or polyethylene in 0.5, 1.0, 2.0 and also
4.0 FL.OZ. 5izes. Each MPAK size ttlbe will be produced on its own
line trom the injection molding, printing, assembly, and packaging.
The integrity of the MPAlC has already been proven by laboratory and
field testing.
continued:
From 'nltlal Coa~:":p( 'l'u I'lnlslocd rroduct
."no l.a~.. W"nh Hd S"I,,,, 20<;1\ . I.d:(" 'Wo(th. fL J"46:, . Tel, 140J) y65.1130 · Fa:c., (401) 96,\".(711
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Tim P~ge. peA Operat~on~
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AL [~r~t, the virgin plastic material will be purchased in large
"Gaylord" containers that holds roughly 2,000 lbs of :&aterlal. Later
on, as the demand for lhe MPAK tubes increase, we anticipate a bulk
plastic handlIng system that will use a "silo" to house & store the
m~leritll. We anticipate that the silo height to be well under the
maximum height o~ 15 ft currently on the Boynton Beach books. The
plCi~lic: injection molding operation will be cont!).ned in its own
area with no dust or particulates dispensed into the environment.
1\11 environmental regulations as prescribed by EPA, OSHA or Boynton
Beach authorities will be followed.
Tube A~E"~mbly:
Once the basic MPAK tube 1s rnolde~ it must be assembled with other
components to make it into a working, non-aerosol spray unlt. We
must insert the modular, non-aerosol pump valve and then attatch
the actuator. The actuator 1s the component which when depressed
allows the product to be dispensed as a spray. The MPAK twist-lock
actuator has two pos~tlons. One position locks the actuator so that
it cunnot spray and by twisting the actuator with the thumb into
the second posit1on allows the unit to spray. The bottom end of the
MPAK container is open which will be described more fully under Liquid
Packaging.
'rhe [.Lnal phClse of the assembly operation is to print the label on
UI~ uuler tube surface. We anticipate using an offset printing machine
UICiL .L~ capabl~ of prjnting up to 4 different colors. This machine
uses non-toxic UV inks that come in paste form The colored ink paste
~s appli~d to its own blanket which in turn supplies the printing
h9nd with the ink.
The printing sequence while simple to watch is very technical &.
a precise art to produce perfect printing each and every time. The
MPAK tube described above with its bottom end open is slid onto a
mandrel and locked in position. The mandrel moves upward in a circle
to automatically cause the "corona", an electrica.l charge to excite
the plastic ~urfdce to become receptive to the printing inks. As
the drum revolves, each color is applied per the label artwork
Just prior to being released at the bottom of the circle the wet
~.IIk:;; ;;u:e subjected to an Ultra-Violet light source that instantly
dries and cures the ink in a fraction of a second. The printQd
tube i5 automatically ejected from the mandrel and a new virgin
Ml'AK tube slid into place to repeat the cycle. The ejected tube is
now ready for liquld packaging.
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Liquid packaqinS2
The PCA operation is only geared to liquid fill manufacture. The
anticipated line will consist not only of OTC drug items (Non-aerosol
Antifungal liquids, Anesthetic spra.ys, Hydrocortisone Sprays, metered
dose inhalers for Asthma, Nasal sprays, Nasal insulin dispensing,
Ant~-1n~Lammatory sprays), plus cosmetic type products (Breath Fresheners,
Lens Cleaners, Personal insect repellent, Antiperspirants,etc). Because
of the anticipated product m~x, peA will get plant approvals from
FDA, EPA and al~o AT&F~
The manufacture of the liquids are done according to approved and
Continued.
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and validated Good Manufacturing Practice (GMP). The concentrate of
each product to be compounded in its own special, enlosed area.
We do not anticipate the use of toxic chemicals or drugs since all
the products produced will be used by humans We do anticipate the
use of alcohol (Ethanol) in specially denatured form using Pepper-
Ul~lll, Spearmint or Wintergreen natural 0115. All alcohols to be
stored << locked area. The use of tbe alcohols is governed by the
I3ureau of Alcohol, Tubacco & Firearms (AT&F). Once the concentrate
is made and approved by Quality Assurance, the product is pumped
to the l.iquid filling machine. After filling the MPM inverted tube,
the bottom piston seal is firmly attatched to the tube rendering
the unit completely seal. The completed tube is packed into is
final cunLauler5 for :5hipment.
Qu~lity A~surance:
AS noetd above the PLA plant will have various federal agency approvals.
~his means that periodically, peA will be inspected by audit by FDA,
EPA and OSHA. Since PCh will manufacture products on a ctract basis
it will be under the scrutiny of those drug companies having products
produced on an almost daily basis. These drug companies send in their
Q.A personnel to audit the entire manufacture operation for adherence
to GMP, Good Laboratory Practice(GLP), etc.
PCA I,"IUS L have ~ ts own staff of technical personnel to maintain the
high standards of Good Manufacturing Practice. peA must analize,
test, inspect all incoming chemicals and raw materials per specifications
defined by both peA and the customer. All manufacturing and testing
to be done by written and approved product protocols under established
Standard Qperatinq proceuures (SOP's).
pe.csonn1:l:
As one can see from the in.cormi;\tion shown above, the various areas
of manufacture can be highly specialized. We anticipate hiring
experienced personnel from the Palm Beach county area if available
If W~ cannot find the experienced personnel we require then we will
need to train them in the following areaa:
Ope.ral:.ion & care of inject.ion molding machines
Operation and Care of offset tube printing & thler machines
Liquid filling line operators
On line quality control inspectors
Chem~c~ compounders, checker, helpers
Quality Assurance inspectors for in-coming, manufacture
and ~inal packaging specificationa
La.boratory analytical technicians
Ware hose & shipping personnel
Orrice :!Staff