Pharma plants · Puerto Rico
Roofing an operating pharma plant in Puerto Rico
Safe for your people, your product and your plant.
Short answer
You can roof over a plant that never stops. Plan it as a safety project, not just another roof.
On a pharma plant, the roof protects three things at once: the people working above and below, the product made underneath, and the plant itself, with its equipment, its insurance and its hurricane resistance. A good project starts with safety prequalification, builds a roof map with EHS and QA, chooses the method by fire and odor risk, closes the roof dry every shift and ends with a closeout package QA can file.
Why now
More investment in plants that are already running
Puerto Rico exported $48,328 million in pharmaceutical products in fiscal 2024, 74% of all its exports, according to DDEC. The Pharmaceutical Industry Association counts 13 member manufacturing plants in seven municipalities. And most investment announced since 2024 goes to campuses that are already producing.
Source: DDEC, Pharmaceutical Profile 2025 and Medical Devices Profile 2025. “Everything else” is the calculated remainder.
Sources: News is my Business (Feb 13, 2024); Amgen (Sept 26, 2025); Lilly (Oct 29, 2025); Caribbean Business (Sept 3, 2026, PharmaEssentia); Amgen (May 4, 2026). Partial list. Public market data; not a list of Mammoth clients.
What that means for the roof, in our view: new roofs tied into old ones, reroofs over lines that do not stop, and new rooftop equipment for air handlers, all next to GMP areas.
Safety comes first
Three things the roof has to protect
Your people
Nobody falls, gets burned or gets hurt. Fall protection, permits, crane lifts and hot work under control.
See sectionYour product
No water, dust or odors reach a classified area. No deviations, no batches at risk, no FDA findings.
See sectionYour plant
The roof does not start a fire or fail in the next hurricane. Fire risk, design wind and your insurer's requirements.
See section
01 · Your people
No one falls and no one gets hurt
Falls are the leading cause of death in construction. In Puerto Rico, safety rules are enforced by PR OSHA, the state plan run by the Department of Labor and Human Resources, which has adopted the federal standards.
“FALLS ARE THE LEADING CAUSE OF DEATH IN CONSTRUCTION. […] These deaths are preventable.”
For the contractor, the rule is 29 CFR 1926.501(b)(10): on a low-slope roof with unprotected edges 6 feet or more above a lower level, every worker must be protected by guardrails, safety nets, personal fall arrest, or a warning line combined with another method. For the plant's own maintenance staff, 29 CFR 1910.28(b)(13) applies, which uses distances from the edge.
There are people below too: operators, technicians and visitors. Material routes, lift zones and areas below the work get closed off and marked.
Source: U.S. Bureau of Labor Statistics, The Economics Daily, May 5, 2026. 95.9% of the construction deaths were falls to a lower level.
Prequalification is the front door
Many pharma and industrial plants prequalify contractors on platforms such as ISNetworld and ask for data like the three-year EMR and TRIR. Each hiring client sets its own requirements. Mammoth is an ISNetworld member. EMR 1.0, within the typical pharma threshold of 1.0 or below. TRIR 0.0 and DART 0.0 in 2025 and 2026 to date (zero recordable injuries).
Download the prequalification checklist (PDF)
Use it with any contractor, including us.
02 · Your product
No water, dust or odor where product is made
To FDA, the roof is part of the facility. A leak over a manufacturing area is not just a maintenance problem: it can become a deviation, an investigation and a finding.
“Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.”
The same part requires buildings of suitable size, construction and location for cleaning, maintenance and proper operations (211.42), and control of air pressure, dust, humidity and temperature when appropriate (211.46). For medical devices, since February 2, 2026 the QMSR (21 CFR 820) applies, incorporating ISO 13485:2016.
“As far as practicable, equipment, fittings and services should be designed and installed so that operations, maintenance, and repairs can be performed outside the cleanroom.”
How product is protected during the work
- Small work zones, closed and dry at the end of every shift.
- Air handler intakes identified and protected; odor-producing work coordinated with engineering.
- Protection of interstitial spaces and ceilings below the work area.
- Material and debris routes kept away from doors and classified areas.
- Safety data sheets for every material delivered before mobilizing.
- QA notified per your procedure if anything happens.
What FDA has written about leaking roofs
| Date | Site | Type | Document | What FDA documented |
|---|---|---|---|---|
| Apr 2026 | Catalent Indiana, Bloomington, Indiana | Sterile fill/finish | Form FDA 483, Apr 24, 2026 | Three roof water intrusion events into classified manufacturing areas in about two months (January to March 2026), with media fills cancelled or aborted and water saturating the interstitial spaces above the suites. “Despite identification of the roof as the source of the leaks, you did not implement effective interim controls or complete corrective actions prior to resuming manufacturing in the affected areas.” The 483 also cites about seven work orders for roof leaks in 2025. |
| Jul 2024 | EyePoint Pharmaceuticals, Watertown, Massachusetts | Drug and device combination product | Warning Letter 679747, Jul 12, 2024 | “investigations into three roof leaks, which resulted in moisture ingress to environmentally controlled manufacturing areas since July 2023, did not identify any long-term preventive action(s).” |
| Jan 2024 | BlendHouse LLC, Reading, Pennsylvania | Infant formula | Form FDA 483, Jan 19, 2024 | Paraphrased: the 483 describes multiple roof leaks during 2023 that reached manufacturing areas in different hygienic zones, several while a lot was in production, and notes that neither the site nor the roofing company could determine the age of the roof's five sections. |
| Sept 2024 | Ice Cream House LLC, Brooklyn, New York | Food (21 CFR 117) | Warning Letter 686641, Sept 24, 2024 | “a tarp was used to funnel leaks from the roof into a hose that emptied into a bucket next to the 3-compartment sink in the (b)(4) room. This roof leak had not been permanently repaired since the previous FDA inspection.” |
None of these cases is a Puerto Rico site. We found no public Puerto Rico 483 or warning letter that cites a roof leak. We include these because they show how FDA looks at a roof: as part of the facility that has to be kept in a good state of repair.
03 · Your plant
No fires, no equipment damage and the insurer on board
The installation method is a safety decision. Open flame, hot asphalt and some adhesives each bring different risks on a plant that runs 24 hours.
“Hot work is one of the three most common causes of fire at FM's client properties.”
“Hundreds of fires have been started by roofer's torches during the installation of torch-applied roof systems.”
FM also recommends shutting down air conditioning units and ventilating fans before torch work starts in surrounding areas. On a plant where air handlers feed classified areas, that is a conversation with engineering and QA before day one, not on the roof.
| Method | Open flame? | Fire risk | Odor and fumes toward air intakes | Cure and weather | What to confirm |
|---|---|---|---|---|---|
| Torch-applied modified bitumen | Yes | Highest on this list. FM Global: “more likely to cause a fire” than installations that use fasteners and adhesives. | Hot asphalt smoke and odor near the flame. | No cure time. FM notes it may be preferred over long-cure adhesives in tropical cyclone areas. | Hot work permit, post-work fire watch, trained applicators, air handlers shut down near the work. |
| Hot asphalt (built-up with a kettle) | Kettle heated by flame | High: hot asphalt and a kettle on the roof or at grade. | Tar odors with a very low odor threshold (parts per billion, per UMN). | Needs a dry window. | Kettle location relative to air intakes and wind; an odor complaint plan. |
| Hot-air welded membrane (TPO or PVC) | No | Low, but the welder is a heat source; many plants still require a permit. | Little odor at the weld; bonding adhesives can have odor. | No cure at the seams; adhesives do need it. | Whether your EHS treats it as hot work; adhesive type and its safety data sheet. |
| Cold-applied or adhesive-adhered | No | Low for flame; some solvent-based adhesives are flammable. | Varies: solvent adhesives give off odor; low-VOC options exist. | Needs cure time and dry weather. | Safety data sheet, VOC content, cure time against the rain and hurricane calendar. |
| Fluid-applied coating (restoration) | No | Low for flame. | Varies with product chemistry. | Needs a dry surface and rain-free windows. | Whether the existing roof qualifies for restoration; manufacturer requirements. |
General guidance, not a specification. Sources: FM Global, Data Sheet 1-33, Safeguarding Torch-Applied Roof Installations (October 2017 edition served on fm.com); FM, Understanding the Hazard: Hot Work (P0032, rev. 09/2024); University of Minnesota, Roofing Odors. Always confirm with the manufacturer's safety data sheet, your EHS team and your insurer.
Hurricanes and code
A roof that holds through the next hurricane
During Maria, in September 2017, Amgen's cameras in Juncos showed that the roof of AML1, the oldest building on the site, had partially collapsed, according to C&EN.
“Crises don't follow the script. Weird things happen.”
“Water intrusion into buildings from roof covering or rooftop equipment failures was a common observation.”
“Unfortunately, most manufacturers are still relying on generator power, and even those that have returned to the electrical grid continue to face interruptions as the grid is rebuilt.”
Source: FEMA P-2020, Mitigation Assessment Team Report, Hurricanes Irma and Maria in Puerto Rico, Table 2-2, October 2018. 3-second gust at 33 ft, Exposure C. The microzone maps (code Appendix P) add topographic speed-up. Always use the project engineer's site value.
Code status as of October 2026
The 2018 Puerto Rico Building Code, based on IBC 2018 and ASCE 7-16, remains in force, with microzone wind maps (Appendix P). The revision is behind schedule, according to El Vocero.
“los códigos de construcción de Puerto Rico son quizás los más restrictivos de los que hay en Estados Unidos, quizás con excepción de Miami, o de California, que son comparativos”
Our translation: Puerto Rico's building codes are perhaps the most restrictive in the United States, perhaps except for Miami or California, which are comparable.
Edges and corners
Many failures start there. Edge metal designed for the project pressure and enhanced securement at the perimeter.
Rooftop equipment
Air handlers, exhaust fans and ducts properly anchored to their curbs, with the roof sealed around them.
Your insurer
If your plant is insured by FM Global, check the assembly in RoofNav and talk to your FM engineer before specifying.
How it is done
A 7-phase protocol for roofing over an operating plant
This is the sequence we propose. It adapts to your site's procedures, not the other way around.
Prequalification and site onboarding
Prequalification platform, EMR, TRIR, written programs, insurance and training verified before the first visit. Site safety orientation and badging for every person.
Walkdown with EHS, QA and engineering
Walk the roof and what is under it with the people responsible for safety, product and equipment. Agree on schedules, routes, restricted zones and who approves what.
Roof zone map
A plan that marks the classified areas below, the air handlers and their intakes, exhaust fans, interstitial spaces, skylights and edges. It is the tool that guides everything else.
Method and materials
Choose the system based on fire risk, odor, dust, noise, design wind and the manufacturer's and insurer's requirements. Safety data sheets are delivered before mobilizing.
Daily controls
Hot work, roof access and lift permits, fall protection, housekeeping, intake protection, and the roof closed and dry at the end of every shift.
Leak contingency
Agree before work starts what happens if water gets in: who gets called, how the product is protected, how the roof is closed temporarily and what gets documented for QA.
Closeout for QA and engineering
As-built drawings, photos, installed materials, the manufacturer warranty and an inspection plan so the roof stays in a good state of repair.
For your bid process
10 questions for any roofing contractor
Ask every bidder, including us. Written answers tell you more than any presentation.
- Which prequalification platform are you on, and what is your grade? What are your three-year EMR and your TRIR?
- Do you have a written fall protection program with a competent person assigned on the roof?
- How do you manage hot work? Do you use torches on operating plants? If so, are your applicators trained?
- Who prepares the lift plan if a crane is needed, and who are the rigger and signal person?
- How will you protect the air intakes and the classified areas below?
- Is the roof closed and dry at the end of every shift? What happens if a downpour hits mid-day?
- What do you hand QA: daily logs, photos, safety data sheets, leak reports, closeout?
- What wind speed and risk category is the proposed system designed for? Is it FM approved if my insurer requires it?
- Which manufacturer warranty applies, and what keeps it in force?
- Which FDA-regulated plants have you worked in, and who can I call as a reference?
Who Mammoth is
What we can show you today
Mammoth Services is a commercial roofing firm with operations in Puerto Rico, led by its owners, Trisha Lira and Mark Lira. In September 2026, a global pharmaceutical manufacturer renewed our master service agreement for recurring roofing work in Puerto Rico for three more years.
- Prequalification
- ISNetworld member
- Manufacturer certification
- 2026 GAF GoldElite Commercial Contractor (GAF ID 1133335)
- GAF warranties on qualified projects
- Diamond Pledge NDL, System Pledge, Integrated System Limited Warranty
- Experience
- 42 years of combined team experience
- EMR
- EMR 1.0, within the typical pharma threshold of 1.0 or below.
- TRIR / DART
- TRIR 0.0 and DART 0.0 in 2025 and 2026 to date (zero recordable injuries).
- Written programs
- Written fall protection, hot work and crane lift plans, with a designated competent person. Provided to clients on request.
- Hot work and torches
- Torch-applied and heat-welded systems installed under the plant's hot work permit, with fire watch and post-work monitoring. Method chosen with the site's EHS team for each area.
- Puerto Rico registration
- Registered to do business in Puerto Rico, with CFSE workers' compensation coverage.
- Pharma experience
- Recurring roofing work in Puerto Rico under a master service agreement with a global pharmaceutical manufacturer, renewed in September 2026 for three more years.
- FM Global
- Experience installing FM Approved roof systems at pharmaceutical manufacturing sites.
- Crews in Puerto Rico
- In-house, bilingual crews in Puerto Rico (Spanish and English).
- GMP training
- Crews have completed client GMP and site orientation training at pharmaceutical and medical device facilities.
FAQ
Frequently asked questions
Can you replace a roof over a cleanroom that is running?
Yes, and it is common, but it is planned with QA before any material moves. The roof is worked in small zones that are closed and dry at the end of every shift, interstitial spaces and air intakes are protected, and production decides which operations can be affected and when. The decision to pause an operation or add environmental monitoring belongs to the plant's quality unit.
Which is better on an operating plant: torch-applied, heat-welded or cold-applied?
It depends on the roof, the insurer and what is underneath. FM Global states that torch-applied roofing is more likely to cause a fire than systems that use fasteners and adhesives. Hot-air welded membranes use no open flame. Cold adhesives avoid flame, but some give off odor and need cure time, and FM also notes that in tropical cyclone areas a torch may be preferred over long-cure adhesives. Decide with your EHS team, your insurance engineer and the specification.
Who handles the FDA paperwork if something happens on the roof?
The plant's quality unit owns deviations and CAPAs. The roofing contractor should give QA what it needs to investigate: daily logs, photos, safety data sheets for the materials, a report of any leak with time and location, and the closeout package with as-built drawings and warranty.
What wind speed applies to my plant in Puerto Rico?
It depends on the building's risk category, location and topography. The 2018 Puerto Rico Building Code uses ASCE 7-16: for Risk Category II, which covers most commercial and industrial buildings, the basic wind speed is 150 to 170 mph before topographic speed-up, and the microzone maps can raise it. Your building's value comes from the project engineer.
My plant is insured by FM Global. Does that change the roof?
Usually, yes. FM has its own data sheets for wind and roof securement and lists approved assemblies in RoofNav. Involve your FM engineer before the system is specified, not after it is installed.
What happens if water gets in mid-project?
The contingency plan agreed before work started kicks in: protect the area and the product, notify QA per your procedure, close the roof temporarily, document it, and find the cause before continuing. FDA has cited plants that resumed manufacturing without effective interim controls after roof leaks.
Does Mammoth work under our permits and safety rules?
Yes. The work plan is built around your site's rules: hot work permits, roof access, lifts, schedules, routes and restricted zones.
Is Mammoth on ISNetworld?
Yes, Mammoth is an ISNetworld member. Requirements and grading are set by each hiring client inside the platform.
Next step
Have a roof over a plant that cannot stop?
Let's start with a walkdown and a roof map with your EHS, QA and engineering team. No obligation.
Sources
All sources were checked on October 7, 2026. Translations of Spanish quotes are ours. This page is informational and does not replace the judgment of your engineer, your insurer or your quality unit.
- DDEC, Puerto Rico's Pharmaceutical Profile 2025 (FY2024)
- DDEC, Puerto Rico's Medical Devices Profile 2025 (FY2024)
- Pharmaceutical Industry Association of Puerto Rico (accessed Oct 7, 2026)
- News is my Business, J&J MedTech $168M (Feb 13, 2024)
- Amgen, $650M expansion (Sept 26, 2025)
- Eli Lilly, more than $1.2B in Puerto Rico (Oct 29, 2025)
- Amgen, additional $300M (May 4, 2026)
- Caribbean Business, Puerto Rico's reshoring wave (Sept 3, 2026)
- OSHA, Fall Prevention Campaign (accessed Oct 7, 2026)
- OSHA, Puerto Rico State Plan (accessed Oct 7, 2026)
- 29 CFR 1926.501 (eCFR)
- 29 CFR 1910.28 (eCFR)
- BLS, National Safety Stand-Down highlights fall hazards in construction (May 5, 2026)
- 21 CFR 211.42 (eCFR)
- 21 CFR 211.46 (eCFR)
- 21 CFR 211.58 (eCFR)
- FDA, Quality Management System Regulation FAQ (effective Feb 2, 2026)
- EU GMP Annex 1, Manufacture of Sterile Medicinal Products (Aug 25, 2022)
- FDA Form 483, Catalent Indiana (Apr 24, 2026)
- FDA Warning Letter 679747, EyePoint Pharmaceuticals (Jul 12, 2024)
- FDA Form 483, BlendHouse LLC (Jan 19, 2024)
- FDA Warning Letter 686641, Ice Cream House LLC (Sept 24, 2024)
- FM, Understanding the Hazard: Hot Work (P0032) (rev. 09/2024)
- FM Data Sheet 1-33, Safeguarding Torch-Applied Roof Installations (Oct 2017)
- University of Minnesota, Roofing Odors (accessed Oct 7, 2026)
- FDA Commissioner Scott Gottlieb, statement on IV fluid shortages (Nov 17, 2017)
- C&EN, Hurricane Maria's lessons for the drug industry (Sept 17, 2018)
- FEMA P-2020, Mitigation Assessment Team Report, Hurricanes Irma and Maria in Puerto Rico (Oct 2018)
- Puerto Rico Building Code 2018 (UpCodes) (effective Nov 15, 2018)
- Appendix P, Microzone Wind Maps for Puerto Rico (2018)
- El Vocero, Atrasada revisión de los Códigos de Construcción (Aug 1, 2026)
- ISNetworld, Contractor Prequalification (accessed Oct 7, 2026)